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Yadagiri M, Kinney FY, Ashman N, Bleasdale JP, Fogden EN, Anderson MR, Walton C, Greenstone MA, Ryder REJ. Endoscopic duodenal-jejunal bypass liner treatment of moderate obstructive sleep apnoea-A pilot study. Clin Obes 2024; 14:e12694. [PMID: 39128971 DOI: 10.1111/cob.12694] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2024] [Accepted: 06/26/2024] [Indexed: 08/13/2024]
Abstract
We aimed to assess the extent to which people with type 2 diabetes or pre-diabetes, obesity (BMI 30-45 kg/m2) and moderate obstructive sleep apnoea (OSA) requiring continuous positive airway pressure ventilation (CPAP) were able to discontinue CPAP following EndoBarrier-related weight loss. We assessed sleep and metabolic parameters before, during and after EndoBarrier in 12 participants with moderate OSA requiring CPAP (75% female, 8/12 [66%] type 2 diabetes, 4/12 [34%] prediabetes, mean ± SD age 52.6 ± 9.7 years, BMI 37.4 ± 3.5 kg/m2, median duration of OSA while on CPAP 9.0 [7.0-15.0] months). With EndoBarrier in-situ, mean ± SD Apnoea Hypopnoea Index (AHI) fell by 9.1 ± 5.0 events/h from 18.9 ± 3.8 to 9.7 ± 3.0 events/h (p < .001) with an associated reduction in symptoms of daytime sleepiness (mean Epworth Sleepiness Score) such that all the 12 participants no longer required CPAP according to National Institute for Health and Care Excellence criteria. After EndoBarrier removal, 10/12 (83%) patients attended follow-up and at 12 months after removal, AHI remained below 15 in 5/10 (50%) patients but in other five the AHI rose above 15 such that restarting CPAP was recommended as justified by their symptoms. Rather than restart CPAP, two patients lost the regained weight and their AHI dropped below 15 again. Thus, 7/10 (70%) of patients were able to remain off CPAP 12 or more months after EndoBarrier removal. These results demonstrate major benefit of EndoBarrier in moderate OSA, allowing all patients to discontinue CPAP during treatment, and with maintenance of improvement at follow-up in 70%. They confirm previously demonstrated metabolic improvements in diabetes and obesity.
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Affiliation(s)
- Mahender Yadagiri
- Diabetes Department, Sandwell & West Birmingham NHS Trust, Birmingham, UK
| | - Fiona Y Kinney
- Research and Development, Sandwell & West Birmingham NHS Trust, Birmingham, UK
| | - Natalie Ashman
- Respiratory Physiology, Sandwell & West Birmingham NHS Trust, City Hospital, Birmingham, UK
| | - John P Bleasdale
- Anaesthetics Department, Sandwell & West Birmingham NHS Trust, City Hospital, Birmingham, UK
| | - Edward N Fogden
- Gastroenterology Department, Sandwell & West Birmingham NHS Trust, City Hospital, Birmingham, UK
| | - Mark R Anderson
- Gastroenterology Department, Sandwell & West Birmingham NHS Trust, City Hospital, Birmingham, UK
| | | | | | - Robert E J Ryder
- Diabetes Department, Sandwell & West Birmingham NHS Trust, Birmingham, UK
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Chen W, Feng J, Dong S, Guo J, Zhou F, Hu S, Hu R, Wang C, Ma Y, Dong Z. Efficacy and safety of duodenal-jejunal bypass liner for obesity and type 2 diabetes: A systematic review and meta-analysis. Obes Rev 2024; 25:e13812. [PMID: 39191438 DOI: 10.1111/obr.13812] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2022] [Revised: 07/18/2024] [Accepted: 07/25/2024] [Indexed: 08/29/2024]
Abstract
This study aimed to evaluate the efficacy and safety of duodenal-jejunal bypass liner (DJBL) for obesity and type 2 diabetes mellitus. A comprehensive search of electronic databases was conducted up to September 15, 2022. Thirty studies involving 1751 patients were included. At 12 months post-implantation, the reduction in body mass index (BMI) was 4.8 kg/m2 (95% CI 4.1, 5.5), with an excess weight loss of 41.3% (95% CI 33.4%,49.2%) and a total weight loss of 13.1% (95% CI 10.1%, 16.0%). Significant decrease was observed in HbA1c and fasting glucose, with a standardized mean difference of - 0.72 (95% CI - 0.95, - 0.48) and - 0.62 (95% CI - 0.82, - 0.42), respectively. However, these improvements in weight loss and glycemic control were only partially sustained after explantation. In situ, DJBL significantly improves blood pressure and lipid levels. The pooled early removal rate was 19%, and the incidence of severe adverse events was 17%, including device migration (6%), gastrointestinal hemorrhage (4%), device obstruction (4%), and hepatic abscess (2%). DJBL offers significant improvement in weight loss and glycemic control, as well as cardiovascular parameters while in situ. Further studies are warranted to better understand the long-term efficacy and safety of DJBL. The benefits of DJBL need to be carefully weighed against the risks in clinical decision-making.
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Affiliation(s)
- Wenhui Chen
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Jia Feng
- Institute of Biomedicine, Department of Cellular Biology, Jinan University, Guangzhou, China
| | - Shiliang Dong
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Jie Guo
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Fuqing Zhou
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Songhao Hu
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Ruixiang Hu
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Cunchuan Wang
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Yi Ma
- Institute of Biomedicine, Department of Cellular Biology, Jinan University, Guangzhou, China
- Key laboratory of Bioengineering Medicine of Guangdong Province, Jinan University, Guangzhou, China
- The National Demonstration Center for Experimental Education of Life Science and Technology, Jinan University, Guangzhou, China
| | - Zhiyong Dong
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
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Hollenbach M, Feisthammel J, Prettin C, Gundling F, Schepp W, Stein J, Petroff D, Hoffmeister A. Weight-Loss Endoscopy Trial: A Multicenter, Randomized, Controlled Trial Comparing Weight Loss in Endoscopically Implanted Duodenal-Jejunal Bypass Liners versus Intragastric Balloons versus a Sham Procedure. Digestion 2024; 105:468-479. [PMID: 38885635 PMCID: PMC11633907 DOI: 10.1159/000539816] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2023] [Accepted: 06/03/2024] [Indexed: 06/20/2024]
Abstract
INTRODUCTION Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far. METHODS We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications. RESULTS Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare. CONCLUSION Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.
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Affiliation(s)
- Marcus Hollenbach
- Division of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany
| | - Jürgen Feisthammel
- Division of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany
| | | | - Felix Gundling
- Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Clinic, Munich, Germany
| | - Wolfgang Schepp
- Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Clinic, Munich, Germany
| | - Jürgen Stein
- Clinic for Internal Medicine, Division of Gastroenterology, Sachsenhausen Clinic, Frankfurt, Germany
| | - David Petroff
- Clinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany
| | - Albrecht Hoffmeister
- Division of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany
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Ren M, Zhou X, Yu M, Cao Y, Xu C, Yu C, Ji F. Prospective study of a new endoscopic duodenal-jejunal bypass sleeve in obese patients with nonalcoholic fatty liver disease (with video). Dig Endosc 2023; 35:58-66. [PMID: 35869797 DOI: 10.1111/den.14409] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/26/2022] [Accepted: 07/19/2022] [Indexed: 01/17/2023]
Abstract
OBJECTIVES To evaluate the safety and efficacy of a new endoscopic duodenal-jejunal bypass sleeve (DJBS) in obese patients with nonalcoholic fatty liver disease (NAFLD), while in situ for 3 months, and at 6 months postexplantation. METHODS Patients with obesity and NAFLD were enrolled in this single-center, prospective study, wherein the TONGEE DJBS (Tangji Medical, Hangzhou, China) was implanted for 3 months. Primary outcomes were weight loss and changes in hepatic steatosis. Secondary outcomes included changes in liver enzymes, glycemic control, and lipid profile and device safety. RESULTS Twenty-six patients (age 35.2 ± 7.2 years; 61.5% women) underwent DJBS implantation. At 3 months, bodyweight change from baseline was -8.0 ± 3.6 kg (P < 0.001), corresponding to 8.9 ± 4.0% of total bodyweight. Hepatic steatosis significantly improved based on controlled attenuation parameter, hepatic steatosis index, and fatty liver index (P < 0.001). Liver enzymes, insulin resistance, and metabolic parameters were also improved. At 6 months postexplantation, weight loss and improvements in hepatic steatosis and liver enzyme levels remained statistically significant. Only one patient had a serious adverse event, namely, upper gastrointestinal hemorrhage. CONCLUSIONS Three-month TONGEE DJBS implantation resulted in significant weight loss and improvement in hepatic steatosis, liver enzymes, insulin resistance, and metabolic parameters in obese patients with NAFLD. Randomized controlled trials are required to further elucidate these initial findings.
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Affiliation(s)
- Mengting Ren
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Xinxin Zhou
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Mosang Yu
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Yang Cao
- Department of Nutrition, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Chengfu Xu
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Chaohui Yu
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Feng Ji
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
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Kamocka A, Chidambaram S, Erridge S, Vithlani G, Miras AD, Purkayastha S. Length of biliopancreatic limb in Roux-en-Y gastric bypass and its impact on post-operative outcomes in metabolic and obesity surgery-systematic review and meta-analysis. Int J Obes (Lond) 2022; 46:1983-1991. [PMID: 35927470 PMCID: PMC9584808 DOI: 10.1038/s41366-022-01186-0] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2022] [Revised: 06/28/2022] [Accepted: 07/01/2022] [Indexed: 11/09/2022]
Abstract
BACKGROUND Roux-en-Y gastric bypass (RYGB) is a gold-standard procedure for treatment of obesity and associated comorbidities. No consensus on the optimal design of this operation has been achieved, with various lengths of bypassed small bowel limb lengths being used by bariatric surgeons. This aim of this systematic review and meta-analysis was to determine whether biliopancreatic limb (BPL) length in RYGB affects postoperative outcomes including superior reduction in weight, body mass index (BMI), and resolution of metabolic comorbidities associated with obesity. METHODS A systematic search of the literature was conducted up until 1st June 2021. Meta-analysis of primary outcomes was performed utilising a random-effects model. Statistical significance was determined by p value < 0.05. RESULTS Ten randomised controlled trials were included in the final quantitative analysis. No difference in outcomes following short versus long BLP in RYGB was identified at 12-72 months post-operatively, namely in BMI reduction, remission or improvement of type 2 diabetes mellitus, hypertension, dyslipidaemia, and complications (p > 0.05). Even though results of four studies showed superior total body weight loss in the long BPL cohorts at 24 months post-operatively (pooled mean difference -6.92, 95% CI -12.37, -1.48, p = 0.01), this outcome was not observed at any other timepoint. CONCLUSION Based on the outcomes of the present study, there is no definitive evidence to suggest that alteration of the BPL affects the quantity of weight loss or resolution of co-existent metabolic comorbidities associated with obesity.
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Affiliation(s)
- Anna Kamocka
- Department of Metabolism, Digestion and Reproduction, Hammersmith Hospital, Imperial College London, 6th Floor Commonwealth Building, Du Cane Road, London, W12 0NN, UK.
| | | | - Simon Erridge
- Department of Surgery and Cancer, Imperial College London, London, SW7 2AZ, UK
| | - Gauri Vithlani
- Department of Surgery and Cancer, Imperial College London, London, SW7 2AZ, UK
| | - Alexander Dimitri Miras
- Department of Metabolism, Digestion and Reproduction, Hammersmith Hospital, Imperial College London, 6th Floor Commonwealth Building, Du Cane Road, London, W12 0NN, UK
- School of Medicine, Ulster University, London, UK
| | - Sanjay Purkayastha
- Department of Surgery and Cancer, Imperial College London, London, SW7 2AZ, UK
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Lo T, Lee Y, Tseng CY, Hu Y, Connelly MA, Mantzoros CS, Karp JM, Tavakkoli A. Daily transient coating of the intestine leads to weight loss and improved glucose tolerance. Metabolism 2022; 126:154917. [PMID: 34687727 PMCID: PMC8666968 DOI: 10.1016/j.metabol.2021.154917] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2021] [Revised: 10/13/2021] [Accepted: 10/19/2021] [Indexed: 01/03/2023]
Abstract
INTRODUCTION Roux-en-Y gastric bypass surgery (RYGB) has been shown to be the gold standard treatment for obesity associated type-2-diabetes (T2D), however many T2D patients do not qualify or are reluctant to proceed with surgery due to its potential risks and permanent changes to GI anatomy. We have previously described a novel oral formulation, LuCI, that provides a transient coating of the proximal bowel and mimics the effects of RYGB. Herein, we aim to investigate the outcome of chronic LuCI administration on weight and glucose homeostasis. METHODS Sprague-Dawley rats on a high fat diet achieving diet-induced obesity (DIO) received 5 weeks of daily LuCI or normal saline as control (n = 8/group). Daily weights and glucose tolerance were monitored throughout the experiment. At 5 weeks, systemic blood was sampled through a surgically placed jugular vein catheter, before and during an intestinal glucose bolus, to investigate changes in key hormones involved in glucose metabolism. To elucidate the effects of LuCI on nutrient absorption, fecal output and food intake were measured simultaneously with the analysis of homogenized stool samples performed using bomb calorimetry. RESULTS At 5 weeks, LuCI animals weighted 8.3% less and had lower fasting glucose levels than Controls (77.6 ± 3.8 mg/dl vs. 99.1 ± 2.7 mg/dl, P < 0.001). LuCI-treated animals had lower baseline insulin and HOMA-IR. Post-prandially, LuCI group had increased GLP-1 and GIP secretion following a glucose challenge. Serum lipid analysis revealed lowered LDL levels highlighting the potential to not only improve glucose control but also modify cardiovascular risk. We then investigated whether LuCI's effect on proximal bowel exclusion may play a role in energy balance. Bomb calorimetry analysis suggested that LuCI reduced calorie absorption with no difference in caloric consumption. CONCLUSION We demonstrated that LuCI recapitulates the physical and hormonal changes seen after RYGB and can ameliorate weight gain and improve insulin sensitivity in a DIO rat model. Since LuCI's effect is transient and without systemic absorption, LuCI has the potential to be a novel therapy for overweight or obese T2D patients.
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Affiliation(s)
- Tammy Lo
- Laboratory for Surgical and Metabolic Research, Department of Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | - Yuhan Lee
- Department of Anesthesiology, Perioperative, and Pain Medicine, Center for Nanomedicine, Center for Regenerative Therapeutics, Brigham and Women's Hospital, Harvard Medical School, Harvard Stem Cell Institute, Harvard-MIT, Division of Health Sciences and Technology, Boston, MA, USA
| | - Chung-Yi Tseng
- Department of Anesthesiology, Perioperative, and Pain Medicine, Center for Nanomedicine, Center for Regenerative Therapeutics, Brigham and Women's Hospital, Harvard Medical School, Harvard Stem Cell Institute, Harvard-MIT, Division of Health Sciences and Technology, Boston, MA, USA
| | - Yangshuo Hu
- Department of Anesthesiology, Perioperative, and Pain Medicine, Center for Nanomedicine, Center for Regenerative Therapeutics, Brigham and Women's Hospital, Harvard Medical School, Harvard Stem Cell Institute, Harvard-MIT, Division of Health Sciences and Technology, Boston, MA, USA
| | - Margery A Connelly
- Laboratory Corporation of America Holdings (Labcorp), Morrisville, NC, USA
| | - Christos S Mantzoros
- Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Section of Endocrinology, Boston VA Healthcare System, Harvard Medical School, Boston, MA, USA
| | - Jeffrey M Karp
- Department of Anesthesiology, Perioperative, and Pain Medicine, Center for Nanomedicine, Center for Regenerative Therapeutics, Brigham and Women's Hospital, Harvard Medical School, Harvard Stem Cell Institute, Harvard-MIT, Division of Health Sciences and Technology, Boston, MA, USA.
| | - Ali Tavakkoli
- Laboratory for Surgical and Metabolic Research, Department of Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of General and GI Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
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Klemenčič S, Bujišić A, Hribernik NŠ, Battelino T, Homan M, Orel R, Kotnik P. Psychological Outcomes and Predictors of Weight Loss in Adolescents With Severe Obesity Following a Reversible Endoscopic Bariatric Procedure. Front Pediatr 2021; 9:688287. [PMID: 34178903 PMCID: PMC8223602 DOI: 10.3389/fped.2021.688287] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2021] [Accepted: 05/10/2021] [Indexed: 02/06/2023] Open
Abstract
Introduction: Adolescent and children obesity is a growing concern worldwide. Bariatric surgery is used as an effective treatment for adolescents with obesity and provides physical and mental health benefits. Application of alternative, minimally invasive, safe, and reversible endoscopic procedures, such as the Duodenojejunal bypass liner (DJBL), has been recently suggested as an effective treatment for adolescents with obesity. We explored specific psychological outcomes of adolescents with obesity during a year of follow-up after undergoing a reversible endoscopic bariatric procedure, and a year after removal. We were also interested in identifying psychological factors that could predict successful weight loss after the procedure. Methods: Nineteen adolescent with severe obesity undergoing DJBL procedure were psychologically assessed in an open-label, prospective clinical trial (NTC0218393), at the implantation of device and at the removal of device after 12 months. Control group of 26 adolescents with severe obesity were recruited from the same outpatient clinic undergoing only conservative treatment. In addition, adolescents from the intervention group were followed for 12 months after the removal of the device. The Youth Self Report (YSR) was used to assess adolescents' emotional and behavioural problems; The Multidimensional Body-Self Relations Questionnaire (MBSRQ) to assess body image and The Eating Disorder Examination Questionnaire (EDE-Q) to assess attitudes and behaviours related to eating disorder. Results: Significant improvements in somatic complain (F = 12.478, p = 0.001), emotional and behavioural problems (F = 7.169, p = 0.011) and food restraining (F = 9.605, p = 0.004) were found in the intervention group at device removal compared to the control group. Moreover, at the time of device removal compared to baseline, improvements in several psychological outcomes were found (F = 32.178 p = 0.000 for emotional and behavioural problems). Adolescents also became more satisfied with their appearance (F = 6.789, p = 0.019). Majority of observed changes remained stable at the next follow up a year after the device removal. Significant predictors of successful weight loss at device removal were fewer overeating episodes (B = 0.147, p = 0.022) and lower body satisfaction (B = 0.932, p = 0.013). Discussion: Following a reversible bariatric procedure, improvements of psychological (emotional and behavioural) factors were found in adolescents with severe obesity. Psychological predictors of successful weight loss were identified, showing the greatest importance of eating behaviour and body satisfaction in successful weight loss.
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Affiliation(s)
- Simona Klemenčič
- Department of Endocrinology, Diabetes and Metabolism, University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Ana Bujišić
- Community Health Centre Kranj, Kranj, Slovenia
| | | | - Tadej Battelino
- Department of Endocrinology, Diabetes and Metabolism, University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Matjaž Homan
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
- Department of Gastroenterology, Hepatology and Nutrition, University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Rok Orel
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
- Department of Gastroenterology, Hepatology and Nutrition, University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Primož Kotnik
- Department of Endocrinology, Diabetes and Metabolism, University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
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Homan M, Kovač J, Orel R, Battelino T, Kotnik P. Relevant Weight Reduction and Reversed Metabolic Co-morbidities Can Be Achieved by Duodenojejunal Bypass Liner in Adolescents with Morbid Obesity. Obes Surg 2021; 30:1001-1010. [PMID: 31758471 DOI: 10.1007/s11695-019-04279-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND Duodenojejunal bypass liner (DJBL) is an endoscopic, reversible bariatric procedure resulting in weight loss and metabolic co-morbidities improvements in the adults. OBJECTIVES To determine safety and effectiveness of 12-month treatment with DJBL in adolescents with severe obesity (BMI > 35 kg/m2) and co-morbidities. METHODS Post-pubertal subjects were treated with DJBL in an open-label, prospective clinical trial (NTC0218393). They were examined at 3 monthly intervals during the 12 months of DJBL treatment and 12 months of follow-up. RESULTS DJBL was successfully placed in 19/22 adolescents (13 females, mean age (95%CI); 17.3 (16.7-17.9) years, BMI-SDS 3.7 (3.6-3.9)). There were no serious device-related adverse effects. Clinically relevant percent total weight loss (%TWL) (mean (95%CI)) 11.4 (7.4-15.3) % and BMI decrease - 4.9 (- 2.4 to - 7.4) kg/m2 was observed at DJBL removal (n = 19). At 12 months after device removal, %TWL was 4.1 (- 2.6-10.8) % and BMI decrease - 2.6 (0.2 to - 5.4) kg/m2 when compared with values at baseline (n = 13). HOMA-IR (- 2.1 (- 3 to - 1.3), WBISI 1.15 (0.23 to 2.07), total cholesterol, LDL-c, and triglycerides levels also improved during DJBL treatment and relapsed similarly to weight at 12-month follow-up. A decrease in iron stores, Zn, and Se levels was determined during DJBL treatment and spontaneously improved at follow-up. CONCLUSIONS Twelve months of DJBL treatment was safe and effective in adolescents with morbid obesity. Weight regain following device removal and relapse of metabolic complications should be expected.
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Affiliation(s)
- Matjaž Homan
- Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia. .,Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.
| | - Jernej Kovač
- Unit of Special Laboratory Diagnostics, University Children's Hospital, University Medical Center Ljubljana, Vrazov trg 1, SI-1000, Ljubljana, Slovenia
| | - Rok Orel
- Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
| | - Tadej Battelino
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Endocrinology, Diabetes And Metabolism, University Children's Hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
| | - Primož Kotnik
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Endocrinology, Diabetes And Metabolism, University Children's Hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
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Ülger TG, Tayfur M, Çakıroğlu FP, Özcan Ç. The Role of duodenal jejunal bypass liner in obesity treatment. AIMS MEDICAL SCIENCE 2021. [DOI: 10.3934/medsci.2021019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022] Open
Abstract
<abstract>
<p>Endoscopic bariatric procedures including Duedenal Jejunal Bypass Liner (DJBL) have become widespread in obesity treatment in recent years. The aim of this systematic review was to assess the role of DJBL in obesity treatment. A comprehensive search of several databases, including Cochrane Library, PubMed, and Web of Science was conducted to December 2020. Twenty-four clinical studies were assessed. According to the results, it is clear that DJBL provides effective weight reduction at 6–12 months and significant improvements in parameters associated with metabolic syndrome and cardiovascular disease. This technique also has potential to reduce comedications in patients with obesity and type 2 diabetes. Although these positive effects of DJBL are clear, its effect on liver, pancreatic functions, and inflammation markers are not clear yet. In addition, the overall and serious complication (gastrointestinal bleeds, pancreatitis, hepatic abscess, obstruction of the sleeve, biliary colic without cholecystitis and cholangitis) rate causing from the DJBL is very high. DJBL has not been approved by the Food and Drug Administration due to the frequency and severity of complications it causes. While it is certain that DJBL has significant effects on obesity and obesity related comorbidities, the safety aspect needs to be improved.</p>
</abstract>
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Glaysher MA, Ward J, Aldhwayan M, Ruban A, Prechtl CG, Fisk HL, Chhina N, Al-Najim W, Smith C, Klimowska-Nassar N, Johnson N, Falaschetti E, Goldstone AP, Miras AD, Byrne JP, Calder PC, Teare JP. The effect of a duodenal-jejunal bypass liner on lipid profile and blood concentrations of long chain polyunsaturated fatty acids. Clin Nutr 2020; 40:2343-2354. [PMID: 33131909 DOI: 10.1016/j.clnu.2020.10.026] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2020] [Revised: 10/16/2020] [Accepted: 10/16/2020] [Indexed: 12/18/2022]
Abstract
BACKGROUND & AIMS Duodenal-jejunal bypass liners (DJBLs) prevent absorption in the proximal small intestine, the site of fatty acid absorption. We sought to investigate the effects of a DJBL on blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs). METHODS Sub-study of a multicentre, randomised, controlled trial with two treatment groups. Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50 kg/m2 were randomised to receive a DJBL for 12 months or best medical therapy, diet and exercise. Whole plasma PUFA concentrations were determined at baseline, 10 days, 6 and 11.5 months; data were available for n = 70 patients per group. RESULTS Weight loss was significantly greater in the DJBL group compared to controls after 11.5 months: total body weight loss 11.3 ± 5.3% versus 6.0 ± 5.7% (mean difference [95% CI] = 5.27% [3.75, 6.80], p < 0.001). Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid, were significantly lower in the DJBL group than in the control group at 6 and 11.5 months follow-up. Total serum cholesterol, LDL-cholesterol and HDL-cholesterol were also significantly lower in the DJBL group. CONCLUSION One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives. DJBL therapy may need to be offset by maintaining an adequate dietary intake of PUFAs or by supplementation. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02459561.
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Affiliation(s)
| | - James Ward
- University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Madhawi Aldhwayan
- Imperial College London, London, UK; Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia
| | | | | | - Helena L Fisk
- School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK
| | | | - Werd Al-Najim
- Imperial College London, London, UK; Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
| | | | | | | | | | | | | | - James P Byrne
- University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Philip C Calder
- School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK
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Castro M, Guerron AD. Bariatric endoscopy: current primary therapies and endoscopic management of complications and other related conditions. MINI-INVASIVE SURGERY 2020. [DOI: 10.20517/2574-1225.2020.14] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
Abstract
The steady increase in bariatric surgery has led to room for innovation. Endoscopy has become an important tool for evaluation, diagnosis, management of complications, and even for primary bariatric interventions. Leaks are the most feared complication and new endoscopic therapies have been developed such as septotomy, double-pigtail stents, and endoscopic vacuum therapy. Additionally, primary bariatric endoscopic procedures are gaining popularity and the new procedures include intragastric balloons, stoma reduction, aspiration therapy, among others. The altered anatomy and reoperation increase the risk of complications after bariatric surgery, especially when managing conditions like achalasia, gastroparesis, and cholelithiasis. Per-oral endoscopic myotomy, per-oral pyloromyotomy, and endoscopic ultrasound-guided transgastric endoscopic retrograde cholangiopancreatography provide a less invasive approach to address these conditions. This narrative review article intends to expose current endoscopic therapies for the management of primary bariatric procedures, complications and related conditions.
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12
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Wang XQ, Wei YQ, Li P, Zhang ST. Obesity and weight management: What can we do as gastroenterologists? Chronic Dis Transl Med 2020; 6:141-146. [PMID: 32885151 PMCID: PMC7451690 DOI: 10.1016/j.cdtm.2020.07.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2020] [Indexed: 12/12/2022] Open
Affiliation(s)
- Xia-Qing Wang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Yong-Qiu Wei
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Peng Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Shu-Tian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
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13
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Colás A, Varela M, Mraz M, Novak D, Cuesta-Frau D, Vigil L, Benes M, Pelikanova T, Haluzik M, Burda V, Vargas B. Influence of glucometric 'dynamical' variables on duodenal-jejunal bypass liner (DJBL) anthropometric and metabolic outcomes. Diabetes Metab Res Rev 2020; 36:e3287. [PMID: 31916665 DOI: 10.1002/dmrr.3287] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/17/2018] [Revised: 11/19/2019] [Accepted: 12/30/2019] [Indexed: 12/23/2022]
Abstract
BACKGROUND The endoscopically implanted duodenal-jejunal bypass liner (DJBL) is an attractive alternative to bariatric surgery for obese diabetic patients. This article aims to study dynamical aspects of the glycaemic profile that may influence DJBL effects. METHODS Thirty patients underwent DJBL implantation and were followed for 10 months. Continuous glucose monitoring (CGM) was performed before implantation and at month 10. Dynamical variables from CGM were measured: coefficient of variation of glycaemia, mean amplitude of glycaemic excursions (MAGE), detrended fluctuation analysis (DFA), % of time with glycaemia under 6.1 mmol/L (TU6.1), area over 7.8 mmol/L (AO7.8) and time in range. We analysed the correlation between changes in both anthropometric (body mass index, BMI and waist circumference) and metabolic (fasting blood glucose, FBG and HbA1c) variables and dynamical CGM-derived metrics and searched for variables in the basal CGM that could predict successful outcomes. RESULTS There was a poor correlation between anthropometric and metabolic outcomes. There was a strong correlation between anthropometric changes and changes in glycaemic tonic control (∆BMI-∆TU6.1: rho = - 0.67, P < .01) and between metabolic outcomes and glycaemic phasic control (∆FBG-∆AO7.8: r = .60, P < .01). Basal AO7.8 was a powerful predictor of successful metabolic outcome (0.85 in patients with AO7.8 above the median vs 0.31 in patients with AO7.8 below the median: Chi-squared = 5.67, P = .02). CONCLUSIONS In our population, anthropometric outcomes of DJBL correlate with improvement in tonic control of glycaemia, while metabolic outcomes correlate preferentially with improvement in phasic control. Assessment of basal phasic control may help in candidate profiling for DJBL implantation.
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Affiliation(s)
- Ana Colás
- Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
| | - Manuel Varela
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
| | - Milos Mraz
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
- Department of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic
| | - Daniel Novak
- Department of Cybernetics, Czech Technical University in Prague, Prague, Czech Republic
| | - David Cuesta-Frau
- Technological Institute of Informatics, Universitat Politècnica de València, Alcoi, Spain
| | - Luis Vigil
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
| | - Marek Benes
- Hepatogastroenterology Department, Transplantation Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Terezie Pelikanova
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Martin Haluzik
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
- Department of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic
- Laboratory of Experimental Diabetology, Experimental Medicine Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Vaclav Burda
- Department of Cybernetics, Czech Technical University in Prague, Prague, Czech Republic
| | - Borja Vargas
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
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Tatarian T, Rona KA, Shin DH, Chen DG, Ducoin CG, Moore RL, Brunaldi VO, Galvão-Neto M, Ardila-Gatas J, Docimo S, Hourneax de Moura DT, Jirapinyo P, Thompson CC, Billy HT, Roslin MS, Borden B, Zarabi S, Sweigert PJ, Chand B, Pryor AD. Evolving procedural options for the treatment of obesity. Curr Probl Surg 2020; 57:100742. [DOI: 10.1016/j.cpsurg.2020.100742] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
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Effect of the EndoBarrier Device: a 4-Year Follow-up of a Multicenter Randomized Clinical Trial. Obes Surg 2020; 29:1117-1121. [PMID: 30627989 DOI: 10.1007/s11695-018-03659-6] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVE To evaluate the long-term effect of the duodenal-jejunal bypass liner (DJBL) on weight loss and glycemic control. BACKGROUND Data on the long-term effect of DJBL treatment is still missing. METHODS From 2010 to 2012, 29 patients were treated with the DJBL at center A and center B, as part of a multicenter randomized controlled trial. Prior to implantation and after removal of the DJBL, all patients underwent standardized physical examination and blood sampling. Four years after removal of the DJBL, included patients underwent standardized physical examination and blood sampling as previously performed during the initial study. RESULTS Out of the 29 patients, 15 patients were eligible for follow-up with a median duration of 42 months. Five patients had successfully received additional bariatric surgery. Four years after explantation of the DJBL, median weight in these 15 patients was 102.0 kg (IQR 94.0-124.6), which was not statistically significantly different from the 106.1 kg at baseline (IQR 99.0-128.4). Median BMI changed from 33.1 kg/m2 (IQR 32.3-38.5) at baseline to 33.7 kg/m2 (IQR 31.2-36.9) after follow-up. Patients had a TWL of 2.2% (IQR - 1.3-5.6) compared to baseline weight. None of the parameters were significantly different after follow-up compared to baseline. CONCLUSIONS The effect of weight reduction of initial DJBL treatment seems to be diminished after 4 years of follow-up. However, larger prospective studies with long-term follow-up need to be conducted in the future.
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16
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Abstract
Background Obesity surgery mortality risk scoring system (OS-MRS) classifies patients into high, intermediate and low risk, based on age, body mass index, sex and other comorbidities such as hypertension and history of pulmonary embolism. High-risk patients not only have a higher mortality but are more likely to develop post-operative complications necessitating intervention or prolonged hospital stay following bariatric surgery. Endoscopically placed duodenal-jejunal bypass sleeve (Endobarrier) has been designed to achieve weight loss and improve glycaemic control in morbidly obese patients with clinically proven effectiveness. The aim of this study was to assess if pre-operative insertion of endobarrier in high-risk patients can decrease morbidity and length of stay after bariatric surgery. Materials and Methods Between 2012 and 2014, a cohort of 11 high-risk patients had an Endobarrier inserted (E&BS group) for 1 year prior to definitive bariatric surgery. These patients were compared against a similar group undergoing primary bariatric surgery (PBS group) during same duration. The two groups were matched for age, gender, body mass index, comorbidities, surgical procedure and OS-MRS using propensity score matching. Outcome measures included operative time, morbidity, length of stay, intensive therapy unit (ITU) stay, readmission rate, percentage excess weight loss (%EWL) and percentage total weight loss (%TWL). Results Patient characteristics and OS-MRS were similar in both groups (match tolerance 0.1). There was no significant difference in total length of stay, readmission rate, %EWL and %TWL. Operative time, ITU stay, post-operative complications and severity of complications were significantly less in the E&BS group (p < 0.05) with significant likelihood of planned ITU admissions in the PBS group (p < 0.05). Conclusion Endobarrier could be considered as a pre bariatric surgical intervention in high-risk patients. It may result in improved post-operative outcomes in high-risk bariatric patients.
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17
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van Rijn S, Betzel B, de Jonge C, van Dijk DPJ, Janssen IM, Berends FJ, Bouvy ND, Greve JWM. The Effect of 6 and 12 months Duodenal-Jejunal Bypass Liner Treatment on Obesity and Type 2 Diabetes: a Crossover Cohort Study. Obes Surg 2019; 28:1255-1262. [PMID: 29110244 PMCID: PMC5968053 DOI: 10.1007/s11695-017-2997-7] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
OBJECTIVE The aim of this research was to study the duodenal-jejunal bypass liner (DJBL) treatment for obesity and type 2 diabetes mellitus (T2DM) in patients after dietary treatment in a cross-over design. BACKGROUND DJBL treatment has been proven effective for treatment of obesity and T2DM. However, data on safety and efficacy of a 12-month DJBL treatment is limited. METHODS In 2014, our research group reported on a multicenter randomized clinical trial. Patients were randomized to DJBL or dietary treatment (control group). Twenty-eight patients crossed over after their dietary treatment and received up to 12 months of DJBL treatment. Patient visits were conducted at baseline, during DJBL treatment (1 week, 1-6, 9, 12 months) and 6 months after removal of the liner. Patients underwent a standard physical examination, blood sampling, assessment of adverse events, nutritional and diabetes counseling, and a standardized meal tolerance test. RESULTS Of the 28 patients included in this study, 24 patients completed 6 months of treatment. Eighteen patients were extended to 12 months of DJBL treatment; 13 patients completed this treatment period. After 6 months of DJBL treatment, a significant increase in excess weight loss (EWL) and decrease in weight, BMI, HbA1c, fasting glucose, cholesterol, HDL and LDL improved significantly. After 12 months of DJBL treatment, these parameters stabilized. CONCLUSIONS The DJBL is an effective, minimally invasive treatment option. Even after successful treatment with dietary restrictions, the DJBL is still capable of significantly reducing weight and improving cardiovascular and type 2 diabetes mellitus parameters in obese patients.
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Affiliation(s)
- Selwyn van Rijn
- Department of General Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Bark Betzel
- Department of General Surgery, Rijnstate Medical Center, Arnhem, The Netherlands
| | - Charlotte de Jonge
- Department of General Surgery, Zuyderland Medical Center, Heerlen-Sittard, The Netherlands
| | - David P J van Dijk
- Department of General Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Ignace M Janssen
- Department of General Surgery, Rijnstate Medical Center, Arnhem, The Netherlands
| | - Frits J Berends
- Department of General Surgery, Rijnstate Medical Center, Arnhem, The Netherlands
| | - Nicole D Bouvy
- Department of General Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Jan Willem M Greve
- Department of General Surgery, Zuyderland Medical Center, Heerlen-Sittard, The Netherlands. .,, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands.
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18
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Riedel N, Laubner K, Lautenbach A, Schön G, Schlensak M, Stengel R, Eberl T, Dederichs F, Aberle J, Seufert J. Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL). Obes Surg 2019; 28:2187-2196. [PMID: 29504053 DOI: 10.1007/s11695-018-3144-9] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obese patients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report. METHODS Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32). RESULTS For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m2 (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher). CONCLUSION With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obese patients with T2DM. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02731859.
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Affiliation(s)
- Nina Riedel
- Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
| | - Katharina Laubner
- Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany
| | - Anne Lautenbach
- Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany
| | - Gerhard Schön
- Institute of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Matthias Schlensak
- Department of Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany
| | | | | | - Frank Dederichs
- Department of Internal Medicine/Gastroenterology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany
- Department of Internal Medicine/Gastroenterology, Kath, Kliniken Hagen, Hagen, Germany
| | - Jens Aberle
- Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany
| | - Jochen Seufert
- Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany
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Bhandari M, Fobi MAL, Buchwald JN. Standardization of Bariatric Metabolic Procedures: World Consensus Meeting Statement. Obes Surg 2019; 29:309-345. [PMID: 31297742 DOI: 10.1007/s11695-019-04032-x] [Citation(s) in RCA: 88] [Impact Index Per Article: 14.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND Standardization of the key measurements of a procedure's finished anatomic configuration strengthens surgical practice, research, and patient outcomes. A consensus meeting was organized to define standard versions of 25 bariatric metabolic procedures. METHODS A panel of experts in bariatric metabolic surgery from multiple continents was invited to present technique descriptions and outcomes for 4 classic, or conventional, and 21 variant and emerging procedures. Expert panel and audience discussion was followed by electronic voting on proposed standard dimensions and volumes for each procedure's key anatomic alterations. Consensus was defined as ≥ 70% agreement. RESULTS The Bariatric Metabolic Surgery Standardization World Consensus Meeting (BMSS-WOCOM) was convened March 22-24, 2018, in New Delhi, India. Discussion confirmed heterogeneity in procedure measurements in the literature. A set of anatomic measurements to serve as the standard version of each procedure was proposed. After two voting rounds, 22/25 (88.0%) configurations posed for consideration as procedure standards achieved voting consensus by the expert panel, 1 did not attain consensus, and 2 were not voted on. All configurations were voted on by ≥ 50% of 50 expert panelists. The Consensus Statement was developed from scientific evidence collated from presenters' slides and a separate literature review, meeting video, and transcripts. Review and input was provided by consensus panel members. CONCLUSIONS Standard versions of the finished anatomic configurations of 22 surgical procedures were established by expert consensus. The BMSS process was undertaken as a first step in developing evidence-based standard bariatric metabolic surgical procedures with the aim of improving consistency in surgery, data collection, comparison of procedures, and outcome reporting.
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Affiliation(s)
- Mohit Bhandari
- Department of Surgery, Sri Aurobindo Medical College and Postgraduate Institution, Mohak Bariatric and Robotic Surgery Centre, Indore, MP, India.
| | - M A L Fobi
- Department of Surgery, Sri Aurobindo Medical College and Postgraduate Institution, Mohak Bariatric and Robotic Surgery Centre, Indore, MP, India
| | - Jane N Buchwald
- Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA
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Pop R, Kong SH, Langlois A, Marchegiani F, Shlomovitz E, Legnèr A, Bietiger W, Pinget M, Beaujeux R, Mutter D, Marescaux J, Diana M. Gastrointestinal Hormones Manipulation to Counteract Metabolic Syndrome Using Duodenal Targeted Embolization. Surg Innov 2019; 26:280-292. [PMID: 30920898 DOI: 10.1177/1553350619838098] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
PURPOSE Targeted embolization of gastrointestinal (GI) arteries can modify hormonal production. We aimed to evaluate the impact of the embolization of the gastroduodenal artery (GDA) on the activity of foregut mucosa. METHODS The GDA's duodenal branch was embolized in 12 Yucatan pigs using 100-300 µm (group A; n = 4) or 300-500 µm (group B; n = 4) microspheres, followed by coiling of the branch. In 4 animals (sham), only saline was injected. The levels of GI hormones (ghrelin, glucose-dependent insulinotropic peptide [GIP], glucagon-like peptide-1 [GLP-1], insulin, peptide YY [PYY], leptin) and the gene expression of sodium-glucose-linked transporter-1 (SGLT-1) and glucose transporter-2 (GLUT-2) were assessed before (T0), 1 hour (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after embolization. RESULTS In group A, a segmental duodenal stenosis occurred in all cases, which required balloon dilatation. There was a significant drop in the baseline glycemia in group A at T1 and T4 versus sham. Ghrelin was reduced in group A versus baseline and versus group B at T2 and T3 and versus sham at T1 and T3. Insulin was significantly lower in group A versus B at T1 and at T4 but not versus sham. SGLT-1 expression increased in B and sham at T4, while it remained stable in group A. GLUT-2 expression increased in sham at T4 but not in A or B. CONCLUSIONS GDA embolization induced a decrease in ghrelin production and influenced expression of glucose carriers in the foregut mucosa.
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Affiliation(s)
- Raoul Pop
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 2 University Hospital of Strasbourg, Strasbourg, France
| | - Seong-Ho Kong
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 3 Seoul National University Hospital, Seoul, South Korea
| | - Allan Langlois
- 4 European Center for the Study of Diabetes (CEED), Strasbourg, France
| | | | - Eran Shlomovitz
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
| | - András Legnèr
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
| | - William Bietiger
- 4 European Center for the Study of Diabetes (CEED), Strasbourg, France
| | - Michel Pinget
- 4 European Center for the Study of Diabetes (CEED), Strasbourg, France
| | - Rémy Beaujeux
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 2 University Hospital of Strasbourg, Strasbourg, France
| | - Didier Mutter
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 2 University Hospital of Strasbourg, Strasbourg, France
- 5 IRCAD Research Institute Against Cancer of the Digestive System, Strasbourg, France
| | - Jacques Marescaux
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 5 IRCAD Research Institute Against Cancer of the Digestive System, Strasbourg, France
| | - Michele Diana
- 1 IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- 2 University Hospital of Strasbourg, Strasbourg, France
- 5 IRCAD Research Institute Against Cancer of the Digestive System, Strasbourg, France
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van Nierop FS, de Jonge C, Kulik W, Bouvy N, Schaap FG, Olde Damink SW, Rensen S, Romijn JA, Greve JWM, Soeters MR. Duodenal-jejunal lining increases postprandial unconjugated bile acid responses and disrupts the bile acid-FXR-FGF19 axis in humans. Metabolism 2019; 93:25-32. [PMID: 30658059 DOI: 10.1016/j.metabol.2018.12.009] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2018] [Revised: 12/21/2018] [Accepted: 12/29/2018] [Indexed: 12/26/2022]
Abstract
BACKGROUND AND AIMS Placement of the duodenal-jejunal bypass liner (DJBL) leads to rapid weight loss and restoration of insulin sensitivity in a similar fashion to bariatric surgery. Increased systemic bile acid levels are candidate effectors for these effects through postprandial activation of their receptors TGR5 and FXR. We aimed to quantify postprandial bile acid, GLP-1 and FGF19 responses and assess their temporal relation to the weight loss and metabolic and hormonal changes seen after DJBL placement. METHODS We performed mixed meal testing in 17 obese patients with type 2 diabetes mellitus (DM2) directly before, one week after and 6 months after DJBL placement. RESULTS Both fasting and postprandial bile acid levels were unchanged at 1 week after implantation, and greatly increased 6 months after implantation. The increase consisted of unconjugated bile acid species. 3 hour-postprandial GLP-1 levels increased after 1 week and were sustained, whereas FGF19 levels and postprandial plasma courses were unaffected. CONCLUSIONS DJBL placement leads to profound increases in unconjugated bile acid levels after 6 months, similar to the effects of bariatric surgery. The temporal dissociation between the changes in bile acids, GLP-1 and FGF19 and other gut hormone responses warrant caution about the beneficial role of bile acids after DJBL placement. This observational uncontrolled study emphasizes the need for future controlled studies.
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Affiliation(s)
- Frederik Samuel van Nierop
- Amsterdam UMC, University of Amsterdam, Department of Endocrinology and Metabolism, Amsterdam Gastroenterology & Metabolism Research Institute, Meibergdreef 9, Amsterdam, the Netherlands
| | - Charlotte de Jonge
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands
| | - Wim Kulik
- Amsterdam UMC, University of Amsterdam, Department of Clinical Chemistry, Laboratory Genetic Metabolic Diseases, Meibergdreef 9, Amsterdam, the Netherlands
| | - Nicole Bouvy
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands
| | - Frank G Schaap
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Aachen, Germany
| | - Steven W Olde Damink
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Aachen, Germany.; Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands
| | - Sander Rensen
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands
| | - Johannes A Romijn
- Amsterdam UMC, University of Amsterdam, Department of Medicine, Meibergdreef 9, Amsterdam, the Netherlands
| | - Jan Willem M Greve
- Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands; Department of General Surgery, Zuyderland Medical Center, Heerlen-Sittard, the Netherlands
| | - Maarten R Soeters
- Amsterdam UMC, University of Amsterdam, Department of Endocrinology and Metabolism, Amsterdam Gastroenterology & Metabolism Research Institute, Meibergdreef 9, Amsterdam, the Netherlands.
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Metabolic improvement in obese patients after duodenal-jejunal exclusion is associated with intestinal microbiota composition changes. Int J Obes (Lond) 2019; 43:2509-2517. [PMID: 30765893 DOI: 10.1038/s41366-019-0336-x] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/15/2018] [Revised: 12/21/2018] [Accepted: 01/16/2019] [Indexed: 12/23/2022]
Abstract
BACKGROUND Intestinal microbiota have been suggested to play an important role in the pathogenesis of obesity and type 2 diabetes. Bariatric surgery improves both conditions and has been associated with changes in intestinal microbiota composition. We investigated the effect of a nonsurgical bariatric technique on intestinal microbiota composition in relation to metabolic improvement. METHODS Seventeen patients with obesity and type 2 diabetes were treated with the nonsurgical duodenal-jejunal bypass liner, which excludes the proximal 60 cm small intestine from food. Fecal samples as well as metabolic parameters reflecting obesity and type 2 diabetes were obtained from the patients at baseline, after 6 months with the device in situ, and 6 months after explantation. RESULTS After 6 months of treatment, both obesity and type 2 diabetes had improved with a decrease in weight from 106.1 [99.4-123.5] to 97.4 [89.4-114.0] kg and a decrease in HbA1c from 8.5% [7.6-9.2] to 7.2% [6.3-8.1] (both p < 0.05). This was paralleled by an increased abundance of typical small intestinal bacteria such as Proteobacteria, Veillonella, and Lactobacillus spp. in feces. After removal of the duodenal-jejunal bypass liner, fecal microbiota composition was similar to that observed at baseline, despite persistent weight loss. CONCLUSION Improvement of obesity and type 2 diabetes after exclusion of the proximal 60 cm small intestine by treatment with a nonsurgical duodenal-jejunal bypass liner may be promoted by changes in fecal microbiota composition.
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Tripolt NJ, Aberer F, Url J, Högenauer C, Schreiber F, Eherer A, Sourij C, Obermayer AM, Stadlbauer V, Svehlikova E, Brunner M, Kojzar H, Pferschy PN, Pieber TR, Sourij H. Impact of Duodeno-Jejunal Bypass Liner (EndoBarrierTM) Implantation on Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus (T2DM): A Study Protocol for a Pilot Trial. Diabetes Ther 2019; 10:299-309. [PMID: 30539524 PMCID: PMC6349299 DOI: 10.1007/s13300-018-0540-z] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/13/2018] [Indexed: 01/06/2023] Open
Abstract
INTRODUCTION A 60-cm endoscopically implantable duodenal-jejunal bypass liner (Endobarrier™, GI Dynamics, Lexington, MA, USA) has been introduced as a therapeutic option to support weight loss for a selected group of obese subjects with type 2 diabetes mellitus (T2DM). The sleeve prevents contact between chyme and the intestinal mucosa of the upper gastrointestinal tract. The primary aim of this study is to elucidate the changes in insulin sensitivity and beta-cell function after EndoBarrier™ implantation in obese patients with T2DM; changes in gut permeability and gut microbiome are also to be examined. METHODS This is an open, single-center, prospective trial in which ten obese subjects with T2DM and suboptimal glycemic control (glycosylated hemoglobin A1c (HbA1c) level > 48 mmol/mol) are investigated with regards to EndoBarrier™ implantation. The Endobarrier™ is implanted shortly after baseline and left in situ for a period of 36 weeks. Dual-energy X-ray absorptiometry measurement, assessment of beta-cell function and insulin sensitivity as measured by a Botnia clamp procedure, and a mixed-meal tolerance test are performed prior to implantation and at 4, 36, and 64 weeks after implantation. The composition of the gut microbiota is characterized from stool using 454 pyrosequencing of 16S rRNA genes. Gut permeability is assessed by a differential sugar absorption method. PLANNED OUTCOME This study will give mechanistic insights in particulr into changes of insulin sensitivity, beta-cell function or microbiome changes over time in subjects implanted with an EndobarrierTM device. TRIAL REGISTRATION NCT02769728, Registered 12 May 2016. Current Protocol Date/Version: 04 September 2017/Version 1.9.
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Affiliation(s)
- Norbert Joachim Tripolt
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Felix Aberer
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Jasmin Url
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Christoph Högenauer
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Florian Schreiber
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Andreas Eherer
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Caren Sourij
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Anna-Maria Obermayer
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Vanessa Stadlbauer
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Eva Svehlikova
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Martina Brunner
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Harald Kojzar
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Peter Nikolaus Pferschy
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Thomas Rudolf Pieber
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria
| | - Harald Sourij
- Divisions of Endocrinology and Diabetology, Division of Gastroenterology and Hepatology, Medizinische Universitat Graz, Graz, Austria.
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Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, Marra-López Valenciano C, Turró Arau R, Esteban López-Jamar JM, Muñoz-Navas M. Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2019; 111:140-154. [PMID: 30654612 DOI: 10.17235/reed.2019.4922/2017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.
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Kassir R, Gugenheim J, Amor IB, Kassir R, Sauvat F. Trends in BMI, Glycaemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL). Obes Surg 2018; 28:3629-3630. [PMID: 30145630 DOI: 10.1007/s11695-018-3438-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/28/2022]
Affiliation(s)
- Radwan Kassir
- Department of Bariatric Surgery, CHU Félix Guyon, La Réunion, Saint-Denis, La réunion, France.
| | - Jean Gugenheim
- Department of Bariatric Surgery, CHU Archet 2, Nice, France
| | - Imed Ben Amor
- Department of Bariatric Surgery, CHU Archet 2, Nice, France
| | - Rani Kassir
- Department of Pediatric Surgery, CHU Félix Guyon, Saint-Denis, La Réunion, France
| | - Frédérique Sauvat
- Department of Pediatric Surgery, CHU Félix Guyon, Saint-Denis, La Réunion, France
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Laubner K, Riedel N, Fink K, Holl RW, Welp R, Kempe HP, Lautenbach A, Schlensak M, Stengel R, Eberl T, Dederichs F, Schwacha H, Seufert J, Aberle J. Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study. Diabetes Obes Metab 2018; 20:1868-1877. [PMID: 29569313 DOI: 10.1111/dom.13300] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2017] [Revised: 03/15/2018] [Accepted: 03/17/2018] [Indexed: 12/28/2022]
Abstract
AIMS The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.
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MESH Headings
- Anastomosis, Surgical/adverse effects
- Bariatric Surgery/adverse effects
- Body Mass Index
- Case-Control Studies
- Cohort Studies
- Diabetes Mellitus, Type 2/blood
- Diabetes Mellitus, Type 2/complications
- Diabetes Mellitus, Type 2/drug therapy
- Diabetes Mellitus, Type 2/therapy
- Drug Therapy, Combination
- Duodenum/surgery
- Endoscopy, Gastrointestinal/adverse effects
- Endoscopy, Gastrointestinal/instrumentation
- Female
- Follow-Up Studies
- Germany
- Humans
- Hyperglycemia/prevention & control
- Hypoglycemic Agents/therapeutic use
- Jejunum/surgery
- Male
- Middle Aged
- Obesity, Morbid/blood
- Obesity, Morbid/complications
- Obesity, Morbid/surgery
- Obesity, Morbid/therapy
- Postoperative Complications/prevention & control
- Prospective Studies
- Registries
- Risk Assessment
- Weight Loss
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Affiliation(s)
- Katharina Laubner
- Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany
| | - Nina Riedel
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Katharina Fink
- Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany
- German Center for Diabetes Research, Munich-Neuherberg, Germany
| | - Reinhard W Holl
- Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany
- German Center for Diabetes Research, Munich-Neuherberg, Germany
| | - Reinhard Welp
- Clinic for Internal Medicine, Knappschaftskrankenhaus Bottrop, Bottrop, Germany
| | | | - Anne Lautenbach
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Matthias Schlensak
- Department of Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany
| | | | | | - Frank Dederichs
- Department of Internal Medicine/Gastroenterology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany
- Department of Internal Medicine/Gastroenterology, Kath. Kliniken Hagen, Hagen, Germany
| | - Henning Schwacha
- Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany
| | - Jochen Seufert
- Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany
| | - Jens Aberle
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
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Hollenbach M, Prettin C, Gundling F, Schepp W, Seufert J, Stein J, Rösch T, Aberle J, Feisthammel J, Petroff D, Hoffmeister A. Design of the Weight-loss Endoscopy Trial (WET): a multi-center, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liners vs. intragastric balloons vs. a sham procedure. BMC Gastroenterol 2018; 18:118. [PMID: 30021518 PMCID: PMC6052668 DOI: 10.1186/s12876-018-0838-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2017] [Accepted: 06/28/2018] [Indexed: 01/14/2023] Open
Abstract
Background Obesity is a global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass are effective but accompanied by risk of serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown to be superior to a sham procedure. Methods We designed a multi-center, randomized, patient and assessor-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities and indication for proton pump inhibitors are randomized to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). All participants undergo regular dietary consultation. The IB will be removed after 6 months, whereas the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in comorbidities, quality of life, complication rates and safety will be evaluated. Discussion This trial could help to identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment. Trial registration 16th January 2017. DRKS00011036. Funded by the German Research Foundation (DFG).
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Affiliation(s)
- Marcus Hollenbach
- Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, University of Leipzig, Liebigstrasse 20, D-04103, Leipzig, Germany.
| | | | - Felix Gundling
- Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology; Bogenhausen Clinic, Munich, Germany
| | - Wolfgang Schepp
- Clinic for Gastroenterology, Hepatology and Gastrointestinal Oncology; Bogenhausen Clinic, Munich, Germany
| | - Jochen Seufert
- Clinic for Internal Medicine II; Division of Endocrinology and Diabetology, University of Freiburg, Freiburg, Germany
| | - Jürgen Stein
- Clinic for Internal Medicine; Division of Gastroenterology; Sachsenhausen Clinic, Frankfurt, Germany
| | - Thomas Rösch
- Clinic for Interdisciplinary Endoscopy; Center for Radiology and Endoscopy, University of Hamburg-Eppendorf, Hamburg, Germany
| | - Jens Aberle
- Clinic for Endocrinology, Diabetology, Adiopsity and Lipids, University of Hamburg- Eppendorf, Hamburg, Germany
| | - Jürgen Feisthammel
- Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, University of Leipzig, Liebigstrasse 20, D-04103, Leipzig, Germany
| | - David Petroff
- Clinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany
| | - Albrecht Hoffmeister
- Department of Medicine, Neurology and Dermatology; Division of Gastroenterology and Rheumatology, University of Leipzig, Liebigstrasse 20, D-04103, Leipzig, Germany
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Longitudinal evaluation of efficacy, safety and nutritional status during one-year treatment with the duodenal-jejunal bypass liner. Surg Obes Relat Dis 2018; 14:769-779. [DOI: 10.1016/j.soard.2018.02.029] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2017] [Revised: 02/08/2018] [Accepted: 02/23/2018] [Indexed: 11/23/2022]
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Jirapinyo P, Haas AV, Thompson CC. Effect of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Patients With Type 2 Diabetes With Obesity: A Meta-analysis With Secondary Analysis on Weight Loss and Hormonal Changes. Diabetes Care 2018; 41:1106-1115. [PMID: 29678867 DOI: 10.2337/dc17-1985] [Citation(s) in RCA: 89] [Impact Index Per Article: 12.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/24/2017] [Accepted: 02/06/2018] [Indexed: 02/03/2023]
Abstract
OBJECTIVE Duodenal-jejunal bypass liner (DJBL) is an endoscopic device that may mimic small bowel mechanisms of Roux-en-Y gastric bypass (RYGB). Previous studies have demonstrated the efficacy of DJBL at inducing weight loss. We assessed the effect of DJBL on glycemic control in patients with type 2 diabetes (T2D) with obesity. RESEARCH DESIGN AND METHODS Data sources included MEDLINE, EMBASE, and Web of Science through 1 July 2017. Included were published studies that assessed DJBL outcomes in obese T2D patients. RESULTS Primary outcomes were change in HbA1c and HOMA of insulin resistance (HOMA-IR). Secondary outcomes were change in weight and gut hormones glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and ghrelin. Seventeen studies were included. At explant, HbA1c decreased by 1.3% [95% CI 1.0, 1.6] and HOMA-IR decreased by 4.6 [2.9, 6.3]. Compared with control subjects, DJBL subjects had greater HbA1c reduction by 0.9% [0.5, 1.3]. Six months after explant, HbA1c remained lower than baseline by 0.9% [0.6, 1.2]. At explant, patients lost 11.3 kg [10.3, 12.2], corresponding to a BMI reduction of 4.1 kg/m2 [3.4, 4.9], total weight loss of 18.9% [7.2, 30.6], and excess weight loss of 36.9% [29.2, 44.6]. The amount of weight loss remained significant at 1 year postexplantation. After DJBL, GIP decreased, whereas GLP-1, PYY, and ghrelin increased. CONCLUSIONS DJBL improves glycemic control and insulin resistance in T2D patients with obesity. DJBL also appears to induce significant weight loss in this population. Additionally, changes in gut hormones suggest mechanisms similar to RYGB. Study limitations included heterogeneity among studies.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, MA.,Harvard Medical School, Boston, MA
| | - Andrea V Haas
- Harvard Medical School, Boston, MA.,Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, MA
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, MA .,Harvard Medical School, Boston, MA
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30
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Forner PM, Ramacciotti T, Farey JE, Lord RV. Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients. Obes Surg 2018; 27:3306-3313. [PMID: 29018990 DOI: 10.1007/s11695-017-2939-4] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device. METHODS Study design: A series of all patients treated by the DJBL at our institutions. OUTCOME MEASUREMENTS Weight loss, biochemical measures, complications. RESULTS Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg (p < 0.0001) within the first 6 months after explantation. CONCLUSIONS The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.
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Affiliation(s)
- Patrice M Forner
- St. Vincent's Centre for Applied Medical Research, Sydney, Australia
| | - Timothy Ramacciotti
- St. Vincent's Centre for Applied Medical Research and University of New South Wales, Suite 606, 438 Victoria Street, Darlinghurst, Sydney, NSW, 2010, Australia.,Department of Surgery, School of Medicine, University of Notre Dame, Sydney, Australia
| | - John E Farey
- St. Vincent's Centre for Applied Medical Research, Sydney, Australia
| | - Reginald V Lord
- St. Vincent's Centre for Applied Medical Research and University of New South Wales, Suite 606, 438 Victoria Street, Darlinghurst, Sydney, NSW, 2010, Australia. .,Department of Surgery, School of Medicine, University of Notre Dame, Sydney, Australia.
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31
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Chen JC, Hsu NY, Lee WJ, Chen SC, Ser KH, Lee YC. Prediction of type 2 diabetes remission after metabolic surgery: a comparison of the individualized metabolic surgery score and the ABCD score. Surg Obes Relat Dis 2018. [PMID: 29526672 DOI: 10.1016/j.soard.2018.01.027] [Citation(s) in RCA: 42] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
BACKGROUND Metabolic surgery has become increasingly accepted for the treatment of type 2 diabetes (T2D). However, there is limited evidence regarding the optimal candidate and surgical procedure. Although a new individualized metabolic surgery (IMS) score was recently proposed for procedure selection, it has yet to be validated. OBJECTIVE To validate the IMS score with regard to remission of T2D after metabolic surgery and compare it with the age, body mass index, C-peptide level, and duration of T2D (ABCD) score. SETTING Hospital-based bariatric center. METHODS A total of 310 T2D patients who underwent gastric bypass and sleeve gastrectomy at an academic center in Taiwan and had a minimum 5-year follow-up (2004-2012) were examined for the predictive power of complete remission using the IMS and the ABCD scoring systems. RESULTS At the 5-year follow-up, weight loss was 27.5%, with mean body mass index decreasing from 37.8 to 27.9 kg/m2, mean glycated hemoglobin decreased from 8.6% to 6.1%, and prolonged remission of T2D achieved in 224 (72.3%) T2D patients. Remission rates were higher in patients who underwent gastric bypass than in those who underwent sleeve gastrectomy (73.6% versus 66.1%; P = .04), regardless of T2D severity, and were 96%, 68%, and 16% in patients with IMS mild, moderate, and severe scores, respectively. Although both scores predicted the success of surgery, the ABCD was better in patients with IMS moderate scores. CONCLUSION Metabolic surgery is an option for T2D patients with obesity. The ABCD score may be better at predicting T2D remission after metabolic surgery compared with the IMS score.
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Affiliation(s)
- Jung-Chien Chen
- Ph.D. Program for Cancer Biology and Drug Discovery, College of Medical Science and Technology, Taipei Medical University and Academia Sinica, Taipei, Taiwan, R.O.C.; Department of Surgery, Min-Sheng General Hospital, Taipei, Taiwan, R.O.C
| | - Nan-Yung Hsu
- Ph.D. Program for Cancer Biology and Drug Discovery, College of Medical Science and Technology, Taipei Medical University and Academia Sinica, Taipei, Taiwan, R.O.C..
| | - Wei-Jei Lee
- Department of Surgery, Min-Sheng General Hospital, Taipei, Taiwan, R.O.C.
| | - Shu-Chun Chen
- Department of Surgery, Min-Sheng General Hospital, Taipei, Taiwan, R.O.C
| | - Kong-Han Ser
- Department of Surgery, Min-Sheng General Hospital, Taipei, Taiwan, R.O.C
| | - Yi-Chih Lee
- Department of International Business, Chien Hsin University of Science and Technology, Taipei, Taiwan, R.O.C
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Heffron SP, Lin BX, Parikh M, Scolaro B, Adelman SJ, Collins HL, Berger JS, Fisher EA. Changes in High-Density Lipoprotein Cholesterol Efflux Capacity After Bariatric Surgery Are Procedure Dependent. Arterioscler Thromb Vasc Biol 2018; 38:245-254. [PMID: 29162605 PMCID: PMC5746465 DOI: 10.1161/atvbaha.117.310102] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2017] [Accepted: 11/03/2017] [Indexed: 01/05/2023]
Abstract
OBJECTIVE High-density lipoprotein cholesterol efflux capacity (CEC) is inversely associated with incident cardiovascular events, independent of high-density lipoprotein cholesterol. Obesity is often characterized by impaired high-density lipoprotein function. However, the effects of different bariatric surgical techniques on CEC have not been compared. This study sought to determine the effects of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on CEC. APPROACH AND RESULTS We prospectively studied severely obese, nondiabetic, premenopausal Hispanic women not using lipid medications undergoing RYGB (n=31) or SG (n=36). Subjects were examined before and at 6 and 12 months after surgery. There were no differences in baseline characteristics between surgical groups. Preoperative CEC correlated most strongly with Apo A1 (apolipoprotein A1) concentration but did not correlate with body mass index, waist:hip, high-sensitivity C-reactive protein, or measures of insulin resistance. After 6 months, SG produced superior response in high-density lipoprotein cholesterol and Apo A1 quantity, as well as global and non-ABCA1 (ATP-binding cassette transporter A1)-mediated CEC (P=0.048, P=0.018, respectively) versus RYGB. In multivariable regression models, only procedure type was predictive of changes in CEC (P=0.05). At 12 months after SG, CEC was equivalent to that of normal body mass index control subjects, whereas it remained impaired after RYGB. CONCLUSIONS SG and RYGB produce similar weight loss, but contrasting effects on CEC. These findings may be relevant in discussions about the type of procedure that is most appropriate for a particular obese patient. Further study of the mechanisms underlying these changes may lead to improved understanding of the factors governing CEC and potential therapeutic interventions to maximally reduce cardiovascular disease risk in both obese and nonobese patients.
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Affiliation(s)
- Sean P Heffron
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.).
| | - Bing-Xue Lin
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Manish Parikh
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Bianca Scolaro
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Steven J Adelman
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Heidi L Collins
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Jeffrey S Berger
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
| | - Edward A Fisher
- From the Department of Medicine, Leon H. Charney Division of Cardiology and the Center for the Prevention of Cardiovascular Disease (S.P.H., B.L., J.S.B., E.A.F.), Department of Surgery (M.P.), and Department of Surgery, Division of Vascular Surgery, New York University Langone Medical Center (J.S.B.), New York University School of Medicine, New York; Department of Food Science and Experimental Nutrition, University of Sao Paulo, Brazil (B.S.); and Vascular Strategies LLC, Plymouth Meeting, PA (S.J.A., H.L.C.)
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Glaysher MA, Mohanaruban A, Prechtl CG, Goldstone AP, Miras AD, Lord J, Chhina N, Falaschetti E, Johnson NA, Al-Najim W, Smith C, Li JV, Patel M, Ahmed AR, Moore M, Poulter N, Bloom S, Darzi A, Le Roux C, Byrne JP, Teare JP. A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus. BMJ Open 2017; 7:e018598. [PMID: 29146657 PMCID: PMC5695522 DOI: 10.1136/bmjopen-2017-018598] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
INTRODUCTION The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight. METHODS AND ANALYSIS In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18-65 years with a body mass index 30-50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58-97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression. TRIAL REGISTRATION NUMBER ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.
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Affiliation(s)
- Michael Alan Glaysher
- Southampton Biomedical Research Centre, University Hospital Southampton, Southampton, Hampshire, UK
| | | | | | - Anthony P Goldstone
- PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK
| | - Alexander Dimitri Miras
- Division of Diabetes, Endocrinology and Metabolic Medicine, Hammersmith Hospital, London, UK
| | - Joanne Lord
- Southampton HTA Centre, University of Southampton, University of Southampton Science Park, Southampton, UK
| | - Navpreet Chhina
- Computational Cognitive and Clinical Neuroimaging Group, Hammersmith Hospital, Imperial College London, London, UK
| | | | | | - Werd Al-Najim
- Department of Investigative Medicine, Imperial College London, London, UK
- Diabetes Complications Research Centre, Conway Institute, Dublin, Ireland
- School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
| | - Claire Smith
- Imperial Clinical Trials Unit, Imperial College London, London, UK
| | - Jia V Li
- Division of Computational and Systems Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
| | - Mayank Patel
- Department of Diabetes and Endocrinology, Southampton General Hospital, Southampton, UK
| | - Ahmed R Ahmed
- Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK
| | - Michael Moore
- Primary Care Medical Group, University of Southampton Medical School, Southampton, UK
| | - Neil Poulter
- Imperial Clinical Trials Unit, Imperial College London, London, UK
| | - Stephen Bloom
- North West London Pathology, Head of Division of Diabetes, Endocrinology and Metabolism, Imperial College London, Hammersmith Hospital, London, UK
| | - Ara Darzi
- Division of Surgery, Imperial College London, London, UK
| | - Carel Le Roux
- Head of Pathology, University College Dublin, Dublin, Ireland
| | - James P Byrne
- Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Julian P Teare
- Department of Gastroenterology, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK
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Lee WJ, Almalki O. Recent advancements in bariatric/metabolic surgery. Ann Gastroenterol Surg 2017; 1:171-179. [PMID: 29863165 PMCID: PMC5881368 DOI: 10.1002/ags3.12030] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2017] [Accepted: 06/27/2017] [Indexed: 12/19/2022] Open
Abstract
Obesity and type 2 diabetes mellitus (T2DM) are currently two pan‐endemic health problems worldwide and are associated with considerable increase in morbidity and mortality. Both diseases are closely related and very difficult to control by current medical treatment, including diet, drug therapy and behavioral modification. Bariatric surgery has proven successful in treating not just obesity but also in significantly decreasing overall obesity‐associated morbidities as well as improving quality of life in severely obese patients (body mass index [BMI] >35 kg/m2). A rapid increase in bariatric surgery started in the 2000s when the laparoscopic surgical technique was introduced into this field. Many new procedures had been developed and changed the face of modern bariatric surgery. Recently, bariatric surgery played as gastrointestinal metabolic surgery has been proposed as a new treatment modality for obesity‐related T2DM for patients with BMI >35 kg/m2. Strong evidence has demonstrated that bariatric/metabolic surgery is an effective and durable treatment for obese T2DM patients. Bariatric/metabolic surgery is now becoming an important surgical division. The present article examines and discusses recent advancements in bariatric/metabolic surgery and covers four major fields: (i) the rapid increase in numbers and better safety; (ii) new procedures with better outcomes; (iii) from bariatric to metabolic surgery; and (iv) understanding the mechanisms and personalized treatment.
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Affiliation(s)
- Wei-Jei Lee
- Department of Surgery Min-Sheng General Hospital National Taiwan University Taoyuan Taiwan
| | - Owaid Almalki
- Department of Surgery Min-Sheng General Hospital National Taiwan University Taoyuan Taiwan.,Department of Surgery College of Medicine Taif University Taif Saudi Arabia
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Safety and efficacy of the endoscopic duodenal-jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years. Surg Endosc 2017; 32:260-267. [PMID: 28664427 DOI: 10.1007/s00464-017-5672-0] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2016] [Accepted: 06/13/2017] [Indexed: 01/14/2023]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that mimics the duodenal-jejunal exclusion component of the Roux-en-Y gastric bypass. Previous studies assessing the efficacy of the DJBL have shown 10-40% excess weight loss (%EWL) and improvements in obesity-associated comorbidities. The aim of this study was to evaluate the safety and efficacy of a new DJBL prototype over a 3-year period. METHODS Morbidly obese subjects were enrolled in a single-arm, open-label, prospective trial. The subjects were offered the opportunity to continue with the trial annually and signed a new consent form. The primary endpoint was safety. The secondary endpoints were changes in weight and biochemical parameters from baseline. RESULTS The DJBL was implanted endoscopically in 80 subjects (age: 35±10 years; 69% female; weight: 109±17 kg; BMI: 42±5.4 kg/m2). Seventy-two severe adverse events (AEs) were observed in 55 patients (68%), of which nine subjects required a prolonged hospital stay and three subjects required major interventions. Overall, 23 subjects (29%) underwent early device removal due to AEs. Additionally, 95% of the patients experienced mild AEs that mainly consisted of abdominal pain. The severe AEs included a liver abscess (3), upper GI bleeding (4), cholangitis (1), and acute pancreatitis (1) and mostly occurred after 12 months of follow-up. Two patients presented a short esophageal perforation during explantation. These perforations were successfully managed with endoscopic closure in one subject and medical treatment in the other subject. In the completer population at 52 weeks (71 patients), 104 weeks (40 patients), and 156 weeks (11 patients), the mean %EWL were 44 ± 16, 40 ± 22, and 39 ± 20, respectively (p < 0.001). CONCLUSION This study shows significant and sustained weight loss after 3 years of treatment with the new DJBL. However, the high frequency and severity of AEs preclude the use of this prototype for periods longer than 1 year.
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Liang Y, Yu B, Wang Y, Qiao Z, Cao T, Zhang P. Duodenal long noncoding RNAs are associated with glycemic control after bariatric surgery in high-fat diet-induced diabetic mice. Surg Obes Relat Dis 2017; 13:1212-1226. [PMID: 28366671 DOI: 10.1016/j.soard.2017.02.010] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2016] [Revised: 02/07/2017] [Accepted: 02/09/2017] [Indexed: 02/06/2023]
Abstract
BACKGROUND The duodenum plays a role in the mechanism of type 2 diabetes remission after bariatric surgery. Roux-en-Y gastric bypass (RYGB) may change gene expression in the duodenum and metabolism. Long noncoding RNAs (lncRNAs) constitute a novel class of RNAs that regulate gene expression. Little is known about how duodenal lncRNAs respond to RYGB. Logically, studies on the changes of duodenal lncRNAs potentially can lead to an understanding of the mechanisms of bariatric surgery, as well as discovery of antidiabetic drug targets and biomarkers predicting postoperative outcome. OBJECTIVES To investigate the expression signature of duodenal lncRNAs associated with glycemic improvement by duodenal-jejunal bypass (DJB), a component of RYGB, on a genome-wide scale in high-fat diet-induced diabetic mice. SETTING University medical center. METHODS High fat diet-induced diabetic mice were randomized into 2 groups receiving either the DJB or a sham procedure. Microarray was applied to screen the differentially expressed lncRNAs and messenger RNAs (mRNAs) in the duodenum between the DJB and sham groups, and the result was validated by quantitative real-time polymerase chain reaction in another cohort of animals. Gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analyses were performed to predict the potential lncRNA functions. Based on Pearson correlation analysis, the lncRNA-mRNA and lncRNA-transcription factor (TF) interaction networks were constructed to identify and rank core regulatory lncRNAs and transcription factors. RESULTS A total of 301 lncRNAs, including 232 that were upregulated and 69 downregulated (fold change≥2.0), were differentially expressed in the duodenum between the DJB and sham groups. GO enrichment indicated that these lncRNA-coexpressed mRNAs were correlated with biological processes including cell proliferation, digestion, and catabolic and biosynthetic processes. KEGG pathway analysis revealed that in addition to the digestion and absorption signaling pathways, pancreatic secretion- and inflammatory process-related signaling pathways were mostly enriched in the DJB group. In addition, the lncRNA-mRNA interaction network combined with GO and KEGG pathway analysis suggested that as a top-ranked gene, NONMMUG021726 may play an important role in the mechanism of type 2 diabetes remission after DJB. CONCLUSION DJB leads to drastic changes in lncRNA and mRNA expressions in the duodenum. The majority of top-ranked lncRNAs and mRNAs have roles in pancreatic secretion and inflammatory processes, implying that bypass of the duodenum may initiate insulin secretion and attenuate inflammation. In addition, modulators of such lncRNAs, most likely NONMMUG021726, have potential to become therapeutic targets or biomarkers for prediction of the outcomes of bariatric surgery.
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Affiliation(s)
- Yongjun Liang
- Center for Medical Research and Innovation, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China
| | - Bo Yu
- Center for Metabolic and Bariatric Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China
| | - Yueqian Wang
- Center for Medical Research and Innovation, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China
| | - Zhengdong Qiao
- Center for Medical Research and Innovation, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China
| | - Ting Cao
- Center for Medical Research and Innovation, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China
| | - Peng Zhang
- Center for Medical Research and Innovation, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China; Center for Metabolic and Bariatric Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.
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Rohde U, Federspiel CA, Vilmann P, Langholz E, Friis SU, Krakauer M, Rehfeld JF, Holst JJ, Vilsbøll T, Knop FK. The impact of EndoBarrier gastrointestinal liner in obese patients with normal glucose tolerance and in patients with type 2 diabetes. Diabetes Obes Metab 2017; 19:189-199. [PMID: 27696668 DOI: 10.1111/dom.12800] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2016] [Revised: 09/20/2016] [Accepted: 09/27/2016] [Indexed: 12/31/2022]
Abstract
AIMS The duodenal-jejunal bypass sleeve ((DJBS) or EndoBarrier Gastrointestinal Liner) induces weight loss in obese subjects and may improve glucose homeostasis in patients with type 2 diabetes (T2D). To explore the underlying mechanisms, we evaluated postprandial physiology including glucose metabolism, gut hormone secretion, gallbladder emptying, appetite and food intake in patients undergoing DJBS treatment. MATERIAL AND METHODS A total of 10 normal glucose-tolerant (NGT) obese subjects and 9 age-, body weight- and body mass index-matched metformin-treated T2D patients underwent a liquid mixed meal test and a subsequent ad libitum meal test before implantation with DJBS and 1 week (1w) and 26 weeks (26w) after implantation. RESULTS At 26w, both groups had achieved a weight loss of 6 to 7 kg. Postprandial glucagon-like peptide-1 (GLP-1) and peptide YY responses increased at 1w and 26w, but only in T2D subjects. In contrast, glucose-dependent insulinotropic polypeptide responses were reduced only by DJBS in the NGT group. Postprandial glucose, insulin, C-peptide, glucagon, cholecystokinin and gastrin responses were unaffected by DJBS in both groups. Satiety and fullness sensations were stronger and food intake was reduced at 1w in NGT subjects; no changes in appetite measures or food intake were observed in the T2D group. No effect of DJBS on postprandial gallbladder emptying was observed, and gastric emptying was not delayed. CONCLUSIONS DJBS-induced weight loss was associated with only marginal changes in postprandial physiology, which may explain the absence of effect on postprandial glucose metabolism.
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Affiliation(s)
- Ulrich Rohde
- Center for Diabetes Research, Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - Cecilie A Federspiel
- Center for Diabetes Research, Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - Peter Vilmann
- GastroUnit, Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark
| | - Ebbe Langholz
- Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - Steffen U Friis
- Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - Martin Krakauer
- Department of Clinical Physiology and Nuclear Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - Jens F Rehfeld
- Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
| | - Jens J Holst
- Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - Tina Vilsbøll
- Center for Diabetes Research, Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - Filip K Knop
- Center for Diabetes Research, Department of Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Betzel B, Koehestanie P, Homan J, Aarts EO, Janssen IMC, de Boer H, Wahab PJ, Groenen MJM, Berends FJ. Changes in glycemic control and body weight after explantation of the duodenal-jejunal bypass liner. Gastrointest Endosc 2017; 85:409-415. [PMID: 27451295 DOI: 10.1016/j.gie.2016.07.027] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2015] [Accepted: 07/01/2016] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL explantation on glycemic control and body weight. METHODS This prospective, observational study included only patients with T2DM who had the DJBL implanted for at least 6 months and had a follow-up of at least 12 months after explantation. The primary endpoints were changes in glycosylated hemoglobin A1c (HbA1c) and body weight during the 12 months after explantation. Secondary endpoints were changes in fasting plasma glucose, blood pressure, and plasma lipid levels. RESULTS In total, 59 patients completed the 12-month follow-up after explantation. During this period body weight increased by 5.6 (standard deviation, 6.4) kg (P < .001) and HbA1c rose from 65 (SD 17) to 70 (SD 20) mmol/mol (P < .001). However, body weight remained 8.0 (SD 8.6) kg (P < .001) lower than before implantation, that is, corresponding to a net total body weight loss of 7.4% (SD 7.6) (P < .001). Although HbA1c was significantly higher 12 months after explantation compared with baseline and the mean daily dose of insulin used was comparable, the number of patients on insulin remained significantly lower than before implantation. CONCLUSIONS Explantation of the DJBL is associated with weight gain and worsening of glycemic control, although some beneficial effects remained detectable 12 months after explantation. A change in strategy is needed to preserve the beneficial effects of DJBL treatment. (Clinical trial registration number: 746∖100111.).
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Affiliation(s)
- Bark Betzel
- Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | | | - Jens Homan
- Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Edo O Aarts
- Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | | | - Hans de Boer
- Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands
| | - Peter J Wahab
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Marcel J M Groenen
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Frits J Berends
- Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands
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Abstract
Insufficient hepatic O2 in animal and human studies has been shown to elicit a hepatorenal reflex in response to increased hepatic adenosine, resulting in the stimulation of renal as well as muscle sympathetic nerve activity and activating the renin angiotensin system. Low hepatic ATP, hyperuricemia, and hepatic lipid accumulation reported in metabolic syndrome (MetS) patients may reflect insufficient hepatic O2 delivery, potentially accounting for the sympathetic overdrive associated with MetS. This theoretical concept is supported by experimental results in animals fed a high fructose diet to induce MetS. Hepatic fructose metabolism rapidly consumes ATP resulting in increased adenosine production and hyperuricemia as well as elevated renin release and sympathetic activity. This review makes the case for the hepatorenal reflex causing sympathetic overdrive and metabolic syndrome in response to exaggerated splanchnic oxygen consumption from excessive eating. This is strongly reinforced by the fact that MetS is cured in a matter of days in a significant percentage of patients by diet, bariatric surgery, or endoluminal sleeve, all of which would decrease splanchnic oxygen demand by limiting nutrient contact with the mucosa and reducing the nutrient load due to loss of appetite or dietary restriction.
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Affiliation(s)
- Michael D Wider
- Department of Physiology, Wayne State University School of Medicine, Detroit, Michigan, USA
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Betzel B, Homan J, Aarts EO, Janssen IMC, de Boer H, Wahab PJ, Groenen MJM, Berends FJ. Weight reduction and improvement in diabetes by the duodenal-jejunal bypass liner: a 198 patient cohort study. Surg Endosc 2016; 31:2881-2891. [PMID: 27804045 DOI: 10.1007/s00464-016-5299-6] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2016] [Accepted: 10/14/2016] [Indexed: 02/08/2023]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is an endoscopic treatment for patients with type 2 diabetes mellitus (T2DM) and (morbid) obesity. The aim of the current study was to determine its efficacy and safety profile. METHODS Inclusion criteria for treatment with a DJBL were: age 18-70 years, BMI 28-45 kg/m2, and T2DM with a HbA1c > 48 mmol/mol. Primary outcomes were changes in HbA1c and body weight. Secondary outcomes included changes in blood pressure, lipids, and anti-diabetic medication. Predictive factors for success of treatment with the DJBL were determined. RESULTS Between 2011 and 2014, 185 out of 198 patients successfully underwent a DJBL implantation procedure, with an intended implantation time of 12 months. In these 185 patients, body weight decreased by 12.8 ± 8.0 kg (total body weight loss of 11.9 ± 6.9 %, p < 0.001), HbA1c decreased from 67 to 61 mmol/mol (p < 0.001) despite a reduction in anti-diabetic medication, and blood pressure and serum lipid levels all decreased. In total, 57 (31 %) DJBLs were explanted early after a median duration of 33 weeks. Adverse events occurred in 17 % of patients. C-peptide ≥1.0 nmol/L and body weight ≥107 kg at screening were independent predictive factors for success. CONCLUSIONS Treatment with the DJBL in T2DM patients with (morbid) obesity results in improvement in glucose control, a reduction in anti-diabetic medication, and significant weight loss. The largest changes are observed within the first 3-6 months. Initial C-peptide levels and body weight may help to select patients with the greatest chance of success.
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Affiliation(s)
- Bark Betzel
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands.
| | - Jens Homan
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Edo O Aarts
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Ignace M C Janssen
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Hans de Boer
- Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands
| | - Peter J Wahab
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands
| | - Marcel J M Groenen
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands
| | - Frits J Berends
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
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41
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Elliott JA, Reynolds JV, le Roux CW, Docherty NG. Physiology, pathophysiology and therapeutic implications of enteroendocrine control of food intake. Expert Rev Endocrinol Metab 2016; 11:475-499. [PMID: 30058920 DOI: 10.1080/17446651.2016.1245140] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
With the increasing prevalence of obesity and its associated comorbidities, strides to improve treatment strategies have enhanced our understanding of the function of the gut in the regulation of food intake. The most successful intervention for obesity to date, bariatric surgery effectively manipulates enteroendocrine physiology to enhance satiety and reduce hunger. Areas covered: In the present article, we provide a detailed overview of the physiology of enteroendocrine control of food intake, and discuss its pathophysiologic correlates and therapeutic implications in both obesity and gastrointestinal disease. Expert commentary: Ongoing research in the field of nutrient sensing by L-cells, as well as understanding the role of the microbiome and bile acid signaling may facilitate the development of novel strategies to combat the rising population health threat associated with obesity. Further refinement of post-prandial satiety gut hormone based therapies, including the development of chimeric peptides exploiting the pleiotropic nature of the gut hormone response, and identification of novel methods of delivery may hold the key to optimization of therapeutic modulation of gut hormone physiology in obesity.
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Affiliation(s)
- Jessie A Elliott
- a Diabetes Complications Research Centre, Conway Institute of Biomedical and Biomolecular Research , University College Dublin , Dublin , Ireland
- b Department of Surgery, Trinity Centre for Health Sciences , Trinity College Dublin and St. James's Hospital , Dublin , Ireland
| | - John V Reynolds
- b Department of Surgery, Trinity Centre for Health Sciences , Trinity College Dublin and St. James's Hospital , Dublin , Ireland
| | - Carel W le Roux
- a Diabetes Complications Research Centre, Conway Institute of Biomedical and Biomolecular Research , University College Dublin , Dublin , Ireland
- c Gastrosurgical Laboratory, Sahlgrenska Academy , University of Gothenburg , Gothenburg , Sweden
| | - Neil G Docherty
- a Diabetes Complications Research Centre, Conway Institute of Biomedical and Biomolecular Research , University College Dublin , Dublin , Ireland
- c Gastrosurgical Laboratory, Sahlgrenska Academy , University of Gothenburg , Gothenburg , Sweden
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Abstract
Insufficient hepatic O2 in animal and human studies has been shown to elicit a hepatorenal reflex in response to increased hepatic adenosine, resulting in stimulation of renal as well as muscle sympathetic nerve activity and activating the renin angiotensin system. Low hepatic ATP, hyperuricemia, and hepatic lipid accumulation reported in metabolic syndrome (MetS) patients may reflect insufficient hepatic O2 delivery, potentially accounting for the sympathetic overdrive associated with MetS. This theoretical concept is supported by experimental results in animals fed a high fructose diet to induce MetS. Hepatic fructose metabolism rapidly consumes ATP resulting in increased adenosine production and hyperuricemia as well as elevated renin release and sympathetic activity. This review makes the case for the hepatorenal reflex causing sympathetic overdrive and metabolic syndrome in response to exaggerated splanchnic oxygen consumption from excessive eating. This is strongly reinforced by the fact that MetS is cured in a matter of days in a significant percentage of patients by diet, bariatric surgery, or endoluminal sleeve, all of which would decrease splanchnic oxygen demand by limiting nutrient contact with the mucosa and reducing the nutrient load due to the loss of appetite or dietary restriction.
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Affiliation(s)
- Michael D Wider
- Department of Physiology, Wayne State University School of Medicine, Detroit, Michigan, USA
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43
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Davis M, Kroh M. Novel Endoscopic and Surgical Techniques for Treatment of Morbid Obesity. Surg Clin North Am 2016; 96:857-73. [DOI: 10.1016/j.suc.2016.03.005] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
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Vilarrasa N, de Gordejuela AGR, Casajoana A, Duran X, Toro S, Espinet E, Galvao M, Vendrell J, López-Urdiales R, Pérez M, Pujol J. Endobarrier® in Grade I Obese Patients with Long-Standing Type 2 Diabetes: Role of Gastrointestinal Hormones in Glucose Metabolism. Obes Surg 2016; 27:569-577. [DOI: 10.1007/s11695-016-2311-0] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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45
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Cohen R, Caravatto PP, Petry TZ. Innovative metabolic operations. Surg Obes Relat Dis 2016; 12:1247-55. [DOI: 10.1016/j.soard.2016.02.034] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2016] [Accepted: 02/23/2016] [Indexed: 02/07/2023]
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46
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Maggi U, Formiga A, Lauro R. Hepatic abscess as a complication of duodenal-jejunal bypass sleeve system and review of the literature. Surg Obes Relat Dis 2016; 12:e47-e50. [DOI: 10.1016/j.soard.2016.02.018] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2016] [Revised: 02/18/2016] [Accepted: 02/18/2016] [Indexed: 12/17/2022]
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47
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Surgical cure for type 2 diabetes by foregut or hindgut operations: a myth or reality? A systematic review. Surg Endosc 2016; 31:25-37. [PMID: 27194257 DOI: 10.1007/s00464-016-4952-4] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2016] [Accepted: 04/18/2016] [Indexed: 02/06/2023]
Abstract
BACKGROUND Bariatric surgery results in remission of type 2 diabetes mellitus in a significant proportion of patients. Animal research has proposed the foregut and hindgut hypotheses as possible mechanisms of remission of T2DM independent of weight loss. These hypotheses have formed the basis of investigational procedures designed to treat T2DM in non-obese (in addition to obese) patients. The aim of this study was to review the procedures that utilise the foregut and hindgut hypotheses to treat T2DM in humans. METHODS A systematic review was conducted to identify the investigational procedures performed in humans that are based on the foregut and hindgut hypotheses and then to assess their outcomes. RESULTS Twenty-four studies reported novel procedures to treat T2DM in humans; only ten utilised glycated haemoglobin A1c (HbA1c) in their definition of remission. Reported remission rates were 20-40 % for duodenal-jejunal bypass (DJB), 73-93 % for duodenal-jejunal bypass with sleeve gastrectomy (DJB-SG), 62.5-100 % for duodenal-jejunal bypass sleeve (DJBS) and 47-95.7 % for ileal interposition with sleeve gastrectomy (II-SG). When using a predetermined level of HbA1c to define remission, the remission rates were lower (27, 63, 0 and 65 %) for DJB, DJB-SG, DJBS and II-SG. CONCLUSIONS The outcomes of the foregut- and hindgut-based procedures are not better than the outcomes of just one of their components, namely sleeve gastrectomy. The complexity of these procedures in addition to their comparable outcomes to a simpler operation questions their utility.
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Rohde U, Hedbäck N, Gluud LL, Vilsbøll T, Knop FK. Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab 2016; 18:300-5. [PMID: 26537317 DOI: 10.1111/dom.12603] [Citation(s) in RCA: 92] [Impact Index Per Article: 10.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2015] [Revised: 10/02/2015] [Accepted: 10/31/2015] [Indexed: 12/13/2022]
Abstract
Compared with bariatric surgery, less invasive and reversible techniques to counteract obesity and type 2 diabetes (T2D) have been developed, including the EndoBarrier Gastrointestinal Liner [duodenal-jejunal bypass sleeve (DJBS)]. We conducted a systematic review and meta-analyses of eligible trials to evaluate the efficacy and safety of the DJBS. Five randomized controlled trials (RCTs; 235 subjects) and 10 observational studies (211 subjects) were included. The risk of bias was evaluated as high in all studies. The mean body mass index ranged from 30 to 49.2 kg/m(2) and 10-100% of the subjects had T2D. Meta-analysis showed that the DJBS was associated with significant mean differences in body weight and excess weight loss of -5.1 kg [95% confidence interval (CI) -7.3, -3.0; four trials; n = 151; I(2) = 37%] and 12.6% (95% CI 9.0, 16.2; four trials; n = 166; I(2) = 24%), respectively, compared with diet modification. The mean differences in glycated haemoglobin (-0.9%; 95% CI -1.8, 0.0) and fasting plasma glucose (-3.7 mM; 95% CI -8.2, 0.8) among subjects with T2D did not reach statistical significance. Adverse events consisted mainly of abdominal pain, nausea and vomiting. No deaths occurred. Future high-quality long-term RCTs are needed to further assess efficacy and safety.
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Affiliation(s)
- U Rohde
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - N Hedbäck
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - L L Gluud
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- GastroUnit, Medical Section, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
| | - T Vilsbøll
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - F K Knop
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- Department of Biomedical Sciences, NNF Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Ting CH, Syu YF, Chen LY, Lee FY, Lee SD, Lee WJ, Chen CY. Perspectives on interventional diabetology: Duodenal exclusion is promising for human type 2 diabetes mellitus remission. Nutrition 2016; 32:141-5. [DOI: 10.1016/j.nut.2015.07.006] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2015] [Revised: 07/14/2015] [Accepted: 07/14/2015] [Indexed: 01/06/2023]
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50
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Betzel B, Koehestanie P, Aarts EO, Dogan K, Homan J, Janssen IMC, Wahab PJ, Groenen MJM, Berends FJ. Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity. Gastrointest Endosc 2015; 82:845-52. [PMID: 25952090 DOI: 10.1016/j.gie.2015.03.1911] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2014] [Accepted: 03/03/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity. OBJECTIVE To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk. DESIGN Single-center observational study. SETTING Tertiary referral center. PATIENTS For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test. INTERVENTIONS Endoscopic implantation of the DJBL. MAIN OUTCOME MEASUREMENTS Adverse events, serious adverse events, early explantation. RESULTS Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases. LIMITATIONS Single-center study. CONCLUSION The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL.
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Affiliation(s)
- Bark Betzel
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | | | - Edo O Aarts
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Kemal Dogan
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Jens Homan
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Ignace M C Janssen
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Peter J Wahab
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Marcel J M Groenen
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Frits J Berends
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
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