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1
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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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2
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Matar RH, Abu Dayyeh BK. Advances in Endoscopic Bariatric and Metabolic Therapies. Gastroenterol Clin North Am 2024; 53:731-745. [PMID: 39489584 DOI: 10.1016/j.gtc.2024.08.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2024]
Abstract
This article presents an overview of endoscopic bariatric and metabolic therapies (EBMTs) as emerging minimally invasive interventions for obesity and its related comorbidities. It explores various gastric and small-bowel endoscopic procedures, including their mechanisms, clinical outcomes, and safety profiles.
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Affiliation(s)
- Reem H Matar
- Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
| | - Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street Southwest, Rochester, MN, USA.
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3
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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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4
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Jirapinyo P, Hadefi A, Thompson CC, Patai ÁV, Pannala R, Goelder SK, Kushnir V, Barthet M, Apovian CM, Boskoski I, Chapman CG, Davidson P, Donatelli G, Kumbhari V, Hayee B, Esker J, Hucl T, Pryor AD, Maselli R, Schulman AR, Pattou F, Zelber-Sagi S, Bain PA, Durieux V, Triantafyllou K, Thosani N, Huberty V, Sullivan S. American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity. Gastrointest Endosc 2024; 99:867-885.e64. [PMID: 38639680 DOI: 10.1016/j.gie.2023.12.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2023] [Accepted: 12/07/2023] [Indexed: 04/20/2024]
Abstract
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
| | - Alia Hadefi
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Árpád V Patai
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary
| | - Rahul Pannala
- Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
| | - Stefan K Goelder
- Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany
| | - Vladimir Kushnir
- Department of Medicine-Division of Gastroenterology, Washington University, Washington University School of Medicine in St Louis, St Louis, Missouri, USA
| | - Marc Barthet
- Department of Hepatogastroenterology, Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Marseille, France
| | - Caroline M Apovian
- Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Ivo Boskoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Centre for Endoscopic Research Therapeutics and Training, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Christopher G Chapman
- Center for Interventional and Therapeutic Endoscopy, Division of Digestive Diseases and Nutrition, Rush University, Chicago, Illinois USA
| | - Paul Davidson
- Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Gianfranco Donatelli
- Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Ramsay Générale de Santé, Paris, France and Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
| | - Bu Hayee
- Division of Gastroenterology, Kings College London, London, United Kingdom
| | - Janelle Esker
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Tomas Hucl
- Department of Gastroenterology and Hepatology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
| | - Aurora D Pryor
- Department of Surgery, Long Island Jewish Medical Center, Queens, New York, USA
| | - Roberta Maselli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy and Humanitas Clinical and Research Center IRCCS, Endoscopy Unit, Rozzano, Italy
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
| | - Francois Pattou
- Department of Endocrine and Metabolic Surgery, CHU Lille, University of Lille, Inserm, Institut Pasteur Lille, Lille, France
| | - Shira Zelber-Sagi
- School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel and Department of Gastroenterology, Tel Aviv Medical Center, Tel Aviv, Israel
| | - Paul A Bain
- Countway Library of Medicine, Harvard Medical School, Boston, Massachusetts, USA
| | - Valérie Durieux
- Bibliothèque des Sciences de la Santé, Université Libre de Bruxelles, Brussels, Belgium
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece
| | - Nirav Thosani
- Center for Interventional Gastroenterology at UTHealth, Division of Gastroenterology Hepatology and Nutrition, McGovern Medical School, Houston, Texas, USA
| | - Vincent Huberty
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Shelby Sullivan
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
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Jirapinyo P, Hadefi A, Thompson CC, Patai ÁV, Pannala R, Goelder SK, Kushnir V, Barthet M, Apovian CM, Boskoski I, Chapman CG, Davidson P, Donatelli G, Kumbhari V, Hayee B, Esker J, Hucl T, Pryor AD, Maselli R, Schulman AR, Pattou F, Zelber-Sagi S, Bain PA, Durieux V, Triantafyllou K, Thosani N, Huberty V, Sullivan S. American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity. Endoscopy 2024; 99:867-885.e64. [PMID: 38639680 DOI: 10.1055/a-2292-2494] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2023] [Accepted: 12/07/2023] [Indexed: 04/21/2024]
Abstract
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
| | - Alia Hadefi
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Árpád V Patai
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary
| | - Rahul Pannala
- Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
| | - Stefan K Goelder
- Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany
| | - Vladimir Kushnir
- Department of Medicine-Division of Gastroenterology, Washington University, Washington University School of Medicine in St Louis, St Louis, Missouri, USA
| | - Marc Barthet
- Department of Hepatogastroenterology, Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Marseille, France
| | - Caroline M Apovian
- Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Ivo Boskoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Centre for Endoscopic Research Therapeutics and Training, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Christopher G Chapman
- Center for Interventional and Therapeutic Endoscopy, Division of Digestive Diseases and Nutrition, Rush University, Chicago, Illinois USA
| | - Paul Davidson
- Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Gianfranco Donatelli
- Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Ramsay Générale de Santé, Paris, France and Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
| | - Bu Hayee
- Division of Gastroenterology, Kings College London, London, United Kingdom
| | - Janelle Esker
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Tomas Hucl
- Department of Gastroenterology and Hepatology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
| | - Aurora D Pryor
- Department of Surgery, Long Island Jewish Medical Center, Queens, New York, USA
| | - Roberta Maselli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy and Humanitas Clinical and Research Center IRCCS, Endoscopy Unit, Rozzano, Italy
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
| | - Francois Pattou
- Department of Endocrine and Metabolic Surgery, CHU Lille, University of Lille, Inserm, Institut Pasteur Lille, Lille, France
| | - Shira Zelber-Sagi
- School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel and Department of Gastroenterology, Tel Aviv Medical Center, Tel Aviv, Israel
| | - Paul A Bain
- Countway Library of Medicine, Harvard Medical School, Boston, Massachusetts, USA
| | - Valérie Durieux
- Bibliothèque des Sciences de la Santé, Université Libre de Bruxelles, Brussels, Belgium
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece
| | - Nirav Thosani
- Center for Interventional Gastroenterology at UTHealth, Division of Gastroenterology Hepatology and Nutrition, McGovern Medical School, Houston, Texas, USA
| | - Vincent Huberty
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Shelby Sullivan
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
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Winder JS, Rodriguez JH. Emerging Endoscopic Interventions in Bariatric Surgery. Gastroenterol Clin North Am 2023; 52:681-689. [PMID: 37919020 DOI: 10.1016/j.gtc.2023.09.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2023]
Abstract
Various endoscopic tools and techniques have been developed to treat obesity and its associated weight-related medical conditions. However, many of these endoscopic treatments may be little known or utilized. This article examines the many endoscopic options that have been developed to treat obesity including gastric aspiration devices, incisionless magnetic anastomotic systems, endoluminal bypass barrier sleeves, primary obesity surgery endoluminal, endoscopic sleeve gastroplasty, and duodenal mucosal resurfacing. We review their development, application, efficacy, and the reported literature on their use and results.
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Affiliation(s)
- Joshua S Winder
- Division of Minimally Invasive and Bariatric Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA
| | - John H Rodriguez
- Department of General Surgery, Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi P.O. Box 112412, United Arab Emirates.
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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: 5] [Impact Index Per Article: 1.7] [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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8
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Chen JH, Yu ZH, Liu QLF, Meng QG, Chen X. Research Progress of Duodenal-Jejunal Bypass Liner in the Treatment of Obesity and Type 2 Diabetes Mellitus. Diabetes Metab Syndr Obes 2022; 15:3319-3327. [PMID: 36329806 PMCID: PMC9624146 DOI: 10.2147/dmso.s382324] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2022] [Accepted: 10/19/2022] [Indexed: 11/06/2022] Open
Abstract
With the development of economy and improvement of people's living standards, the incidence of obesity and type 2 diabetes mellitus (T2DM) has increased significantly and obesity has also become one of the most important risk factors of T2DM. In light of these trends, there have been many ways to take effect in losing weight. However, they also have corresponding deficiencies including inapparent curative effect, complex and incomplete reversible procedures and severe complications. Duodenal-Jejunal Bypass Liner (DJBL), which mimics Roux-en-Y gastric bypass (RYGB), is proved to play a key role in weight loss and control of T2DM. DJBL is reversible, less invasive and is more suitable for the treatment of obesity and T2DM, which is associated with multiple mechanisms, including incretin effect, gastric emptying mechanism, bile acid regulation, intestinal microbiota, inflammatory reaction mechanism and neural mechanism. In our review, we aimed to elaborate DJBL's clinical efficacy, safety and mechanisms in detail.
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Affiliation(s)
- Ji-Hua Chen
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Zi-Han Yu
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Qin-Ling Fei Liu
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Qing-Guo Meng
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Xin Chen
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Correspondence: Xin Chen, Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China, Email
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9
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Balint IB, Csaszar F, Somodi K, Ternyik L, Biro A, Kaposztas Z. Is duodeno-jejunal bypass liner superior to pylorus preserving bariatric surgery in terms of complications and efficacy? Langenbecks Arch Surg 2021; 406:1363-1377. [PMID: 33712874 PMCID: PMC8370966 DOI: 10.1007/s00423-021-02131-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Accepted: 02/09/2021] [Indexed: 12/13/2022]
Abstract
PURPOSE Based on recent scientific evidence, bariatric surgery is more effective in the management of morbid obesity and related comorbidities than conservative therapy. Pylorus preserving surgical procedures (PPBS) such as laparoscopic single-anastomosis duodeno-jejunal or duodeno-ileal bypass with sleeve gastrectomy are modified duodenal switch (DS) surgical techniques. The duodeno-jejunal bypass liner (DJBL) is a novel surgical method in the inventory of metabolism focused manual interventions that excludes duodeno-jejunal mucosa from digestion, mimicking DS procedures without the risk of surgical intervention. The aim of this article is to summarize and compare differences between safety-related features and weight loss outcomes of DJBL and PPBS. METHODS A literature search was conducted in the PubMed database. Records of DJBL-related adverse events (AEs), occurrence of PPBS-related complications and reintervention rates were collected. Mean weight, mean body mass index (BMI), percent of excess of weight loss (EWL%), percent of total weight loss (TWL%) and BMI value alterations were recorded for weight loss outcomes. RESULTS A total of 11 publications on DJBL and 6 publications on PPBS were included, involving 800 and 1462 patients, respectively. The baseline characteristics of the patients were matched. Comparison of DJBL-related AEs and PPBS-related severe complications showed an almost equal risk (risk difference (RD): -0.03 and confidence interval (CI): -0.27 to 0.21), despite higher rates among patients having received endoscopic treatment. Overall AE and complication rates classified by Clavien-Dindo showed that PPBS was superior to DJBL due to an excess risk level of 25% (RD: 0.25, CI: 0.01-0.49). Reintervention rates were more favourable in the PPBS group, without significant differences in risk (RD: -0.03, CI: -0.27 to 0.20). However, PPBS seemed more efficient regarding weight loss outcomes at 1-year follow-up according to raw data, while meta-analysis did not reveal any significant difference (odds ratio (OR): 1.08, CI: 0.74-1.59 for BMI changes). CONCLUSION Only limited conclusions can be made based on our findings. PPBS was superior to DJBL with regard to safety outcomes (GRADE IIB), which failed to support the authors' hypothesis. Surgical procedures showed lower complication rates than the incidence of DJBL-related AEs, although it should be emphasized that the low number of PPBS-related mild to moderate complications reported could be the result of incomplete data recording from the analysed publications. Weight loss outcomes favoured bariatric surgery (GRADE IIB). As the DJBL is implanted into the upper gastrointestinal tract for 6 to 12 months, it seems a promising additional method in the inventory of metabolic interventions.
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Affiliation(s)
- Istvan Bence Balint
- Department of Surgery and Vascular Surgery, Zala County Saint Rafael Hospital, H-8900 Zrinyi Miklos street 1., Zalaegerszeg, Hungary
| | - Ferenc Csaszar
- Doctoral School of Neurosciences, University of Pecs, Pécs, Hungary
| | - Krisztian Somodi
- Department of Surgery, Somogy County Kaposi Mor Teaching Hospital, Kaposvár, Hungary
| | - Laszlo Ternyik
- Department of Surgery, Somogy County Kaposi Mor Teaching Hospital, Kaposvár, Hungary
| | - Adrienn Biro
- Department of Surgery, Somogy County Kaposi Mor Teaching Hospital, Kaposvár, Hungary
| | - Zsolt Kaposztas
- Department of Surgery, Somogy County Kaposi Mor Teaching Hospital, Kaposvár, Hungary
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10
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Winder JS, Rodriguez JH. Emerging Endoscopic Interventions in Bariatric Surgery. Surg Clin North Am 2021; 101:373-379. [PMID: 33743975 DOI: 10.1016/j.suc.2020.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
Although obesity rates are growing across the world, endoscopic modalities to treat obesity and its metabolic consequences are advancing rapidly. Multiple devices and techniques dedicated to weight management are being developed and have either been approved for use or are undergoing clinical trial. This article reviews many of these endoscopic interventions in bariatric surgery, including gastric aspiration devices, incisionless magnetic anastomotic systems, endoluminal bypass barrier sleeves, primary surgery obesity endoluminal, endoscopic sleeve gastroplasty, and duodenal mucosal resurfacing. These effective techniques may serve either as a primary therapy or as a bridge to bariatric surgery.
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Affiliation(s)
- Joshua S Winder
- Section of Surgical Endoscopy, Department of General Surgery, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Avenue, Mail Code A-100, Cleveland, OH 44195, USA
| | - John H Rodriguez
- Section of Surgical Endoscopy, Department of General Surgery, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Avenue, Mail Code A-100, Cleveland, OH 44195, USA.
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11
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Farha J, Abbarh S, Haq Z, Itani MI, Oberbach A, Kumbhari V, Badurdeen D. Endobariatrics and Metabolic Endoscopy: Can We Solve the Obesity Epidemic with Our Scope? Curr Gastroenterol Rep 2020; 22:60. [PMID: 33205261 DOI: 10.1007/s11894-020-00798-8] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/16/2020] [Indexed: 12/15/2022]
Abstract
PURPOSE OF REVIEW Obesity is a chronic relapsing disease that results in cardiovascular disease, diabetes mellitus, and non-alcoholic fatty liver disease. Currently, surgery represents the most effective treatment. However, the advent of minimally invasive endoscopic bariatric therapy (EBT) has shifted the treatment paradigm to less invasive, cost-effective procedures with minimal complications and recovery time that are preferred by patients. In this review, we will describe current and future EBTs, focusing on outcomes and safety. RECENT FINDINGS The endoscope has provided an incisionless portal into the gastrointestinal tract for placement of space-occupying devices and intraluminal procedures. EBTs are no longer solely manipulating anatomic alterations; instead, they aim to improve metabolic parameters such as glycated hemoglobin, low-density lipoprotein, cholesterol, and hepatic indices by targeting the mucosal layer of the gastrointestinal tract. The endoscope has succeeded in facilitating clinically meaningful weight loss and improvement of metabolic parameters. Future, solutions to the obesity epidemic will likely entail genetic testing, evaluation of the microbiome, and delivery of personalized therapy, utilizing combination endoscopic modalities that change the anatomy and physiology of individual patients, with new targets such as the abnormal metabolic signal.
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Affiliation(s)
- Jad Farha
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
| | - Shahem Abbarh
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
| | - Zadid Haq
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
| | - Mohamad I Itani
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
| | - Andreas Oberbach
- Department of Diagnostics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
| | - Dilhana Badurdeen
- Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
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12
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Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB). Ann Surg 2020; 272:696-702. [PMID: 32889869 DOI: 10.1097/sla.0000000000004339] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
OBJECTIVE The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.
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13
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Orlandini B, Gallo C, Boškoski I, Bove V, Costamagna G. Procedures and devices for bariatric and metabolic endoscopy. Ther Adv Gastrointest Endosc 2020; 13:2631774520925647. [PMID: 32548577 PMCID: PMC7271273 DOI: 10.1177/2631774520925647] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Accepted: 04/21/2020] [Indexed: 12/14/2022] Open
Abstract
Obesity is a leading cause of preventable death in developed countries, with a
rising incidence over time. Lifestyle modification, pharmacotherapy, and
bariatric surgery are the mainstays of bariatric therapy, even though burdened
by several limitations in terms of efficacy or safety. Bariatric endoscopy has
been developed in the last decades as a minimally invasive alternative, aimed to
bridge the gap between conservative and interventional conventional therapies.
This review aims to provide an updated overview of the bariatric and metabolic
available endoscopic procedures and to drive the choice of the right procedure
for the right patient.
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Affiliation(s)
- Beatrice Orlandini
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Camilla Gallo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Ivo Boškoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8 00168 Rome, Italy
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Guido Costamagna
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
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14
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Boškoski I, Orlandini B, Gallo C, Bove V, Pontecorvi V, Perri V, Costamagna G. Metabolic endoscopy by duodenal mucosal resurfacing: expert review with critical appraisal of the current technique and results. Expert Rev Gastroenterol Hepatol 2020; 14:375-381. [PMID: 32299266 DOI: 10.1080/17474124.2020.1757429] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
INTRODUCTION Duodenal mucosal resurfacing (DMR) is an endoscopic procedure for type 2 diabetes (T2D) consisting of circumferential hydrothermal ablation of the duodenal mucosa. AREAS COVERED A review was conducted on the reports available up to March-2020. On a total of 79 patients, DMR induced a significant mean HbA1c, FPG and HOMA-IR reduction at 6 months (0.9 ± 0.2%, 1.7 ± 0.5 mmol/L and 2.9 ± 1.1 mUI/L respectively - P < 0.001). DMR metabolic efficacy directly correlates with the length of the ablated mucosa (mean 3 months HbA1c reduction 1.2% vs 2.5% after short and long ablation respectively - P < 0.05), while it is independent of weight-loss. Severe AEs were registered in 3.7% of the cases. EXPERT OPINION DMR plays a promising role in metabolic impairment improvement inducing a morpho-functional duodenal alteration not necessarily depending on weight-loss. Technical-functional improvements of the device and appropriate training aimed at its correct use are needed to lower the rate of severe AEs and technical failure. The current role of DMR needs to be clarified, but it might be proposed for poorly controlled T2D in accurately selected patients. Evidence on DMR is still scanty and further research is mandatory to standardize the endoscopic technique and its indications.
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Affiliation(s)
- Ivo Boškoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Beatrice Orlandini
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Camilla Gallo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Valerio Pontecorvi
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Vincenzo Perri
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
| | - Guido Costamagna
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS , Rome, Italy.,Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore di Roma Largo A. Gemelli , Rome, Italy
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15
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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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16
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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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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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19
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Frydenberg Am HB, Suturin VM, Truong H, Ryan A, Soutorine M. New Anchoring Mechanism and Design of an Endoluminal Duodeno-Jejunal Bypass Liner for Treatment of Obesity: a Pilot Animal Trial. Obes Surg 2019; 29:3081-3085. [PMID: 31127497 DOI: 10.1007/s11695-019-03945-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
OBJECTIVE Complications of bleeding, liver abscess and movement have been associated with previous duodeno-jejunal bypass liner (DJBL) applications in the past. A new anchoring system and design of a DJBL is presented as a pilot study. METHOD A newly designed DJBL device was inserted in 2 pigs and observed over 2 months. RESULTS The newly designed device was anchored and monitored for 1 month in 1 of 2 pigs, the other being passed early. Effectiveness and safety have been shown. CONCLUSION The results of this pilot study warrant further investigation of the modified DJBL setup, which may help solve standing issues associated with the clinical use of a DJB liner.
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Affiliation(s)
- Harry B Frydenberg Am
- Epworth Centre for Bariatric Surgery, Suite 2.1, 173 Lennox Street, Richmond, Victoria, 3121, Australia.
| | - Victor M Suturin
- Department of Physiology Metabolism, Diabetes and Obesity Program, Monash Biomedicine Discovery Institute, Monash University, Clayton, Victoria, Australia
| | - Hien Truong
- Epworth Hospital, Richmond, Victoria, Australia
| | - Andrew Ryan
- TissuPath, Mount Waverley, Melbourne, Victoria, Australia
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20
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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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22
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de Moura EGH, Ribeiro IB, Frazão MSV, Mestieri LHM, de Moura DTH, Dal Bó CMR, Brunaldi VO, de Moura ETH, Nunes GC, Bustamante FAC, Dos Passos Galvão Neto M, Matuguma SE, Bernardo WM, Santo MA. EUS-Guided Intragastric Injection of Botulinum Toxin A in the Preoperative Treatment of Super-Obese Patients: a Randomized Clinical Trial. Obes Surg 2019; 29:32-39. [PMID: 30120640 DOI: 10.1007/s11695-018-3470-y] [Citation(s) in RCA: 27] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Obesity is a disease that is highly prevalent in Brazil, and the associated comorbidities represent a major global public health challenge. Botulinum toxin type A (BTX-A) is a potent neurotoxin and inhibitor of gastric smooth muscle activity. In theory, BTX-A administration should promote early satiety and weight loss because it delays gastric emptying by inhibiting acetylcholine-mediated peristalsis, which is primarily responsible for gastric motility. Because results in the literature are discrepant, the efficacy of intragastric injections of BTX-A as a primary treatment for obesity remains unknown. The objective of this prospective, double-blind, single-center randomized study was to evaluate the effects of endoscopic ultrasound-guided intragastric BTX-A injections, as a bridge to bariatric surgery, in super-obese patients. METHODS Thirty-two super-obese patients were randomized to one of two groups: BTX-A, in which 200 units of BTX-A were injected into the gastric antrum and body; and control, in which the same injections were performed with 0.9% saline. Weight, body mass index (BMI), and loss of excess weight were measured monthly over a 6-month period. Gastric emptying scintigraphy was performed before and after the procedure. RESULTS The patients in both groups showed significant weight loss over the course of the study (p < 0.001). There were no statistically significant differences between the groups regarding weight loss, excess weight, total loss of excess weight, total weight loss, or change in BMI. CONCLUSIONS Intragastric injection of BTX-A does not appear to be an effective method of achieving preoperative weight loss in super-obese patients.
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Affiliation(s)
- Eduardo Guimarães Hourneaux de Moura
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Igor Braga Ribeiro
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil.
| | - Mariana Souza Varela Frazão
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Luiz Henrique Mazzonetto Mestieri
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Diogo Turiani Hourneaux de Moura
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Creusa Maria Roveri Dal Bó
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Vitor Ottoboni Brunaldi
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Eduardo Turiani Hourneaux de Moura
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Gabriel Cairo Nunes
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Fábio Alberto Castillo Bustamante
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | | | - Sergio Eiji Matuguma
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Wanderley Marques Bernardo
- Gastrointestinal Endoscopy Unit - Hospital das Clínicas - HC/FMUSP, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, São Paulo, SP, CEP 05403-000, Brazil
| | - Marco Aurélio Santo
- Bariatric and Metabolic Surgery Unit, Hospital das Clínicas, University of Sao Paulo School of Medicine, São Paulo, Brazil
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Khosravi-Largani M, Nojomi M, Aghili R, Otaghvar HA, Tanha K, Seyedi SHS, Mottaghi A. Evaluation of all Types of Metabolic Bariatric Surgery and its Consequences: a Systematic Review and Meta-Analysis. Obes Surg 2018; 29:651-690. [PMID: 30443720 DOI: 10.1007/s11695-018-3550-z] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
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Deutsch L, Ben Haim L, Sofer Y, Gluck N, Santo E, Fishman S. Long-term effects of proximal small bowel exclusion by duodenal-jejunal bypass liner on weight reduction and glycemic control in diabetic patients. Surg Obes Relat Dis 2018; 14:1561-1569. [PMID: 30449512 DOI: 10.1016/j.soard.2018.07.022] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2018] [Revised: 07/03/2018] [Accepted: 07/20/2018] [Indexed: 12/20/2022]
Abstract
BACKGROUND Exclusion of the proximal gut from nutrient absorption entails significant metabolic benefits. The duodenal-jejunal bypass liner (DJBL) is the first endoscopic device that excludes the first part of the gut by covering it. OBJECTIVES To assess weight and glycemic control at the end of treatment and after 1 year of follow-up. SETTING Bariatric endoscopy service in a tertiary medical center. METHODS Diabetic patients were treated with DJBL and followed prospectively between 2013 and 2016. Data were collected during scheduled visits. RESULTS Out of 51 patients treated, 39 completed at least 9 months with the device. Complications were recorded for the entire cohort. Percent of total weight loss was 15.05% ± 6.0% after 12 months of treatment (P < .001 versus baseline). Twelve months postretrieval, percent of total weight loss decreased to 8.75% ± 5.07% (P < .001 versus baseline). Patients with baseline body mass index ≥35 kg/m2 experienced greater percent total weight loss changes over time (P < .001). There was a significant effect on hemoglobin A1C levels over time (P = .003), and the nadir was reached at 9 months of treatment (median 6.05% versus 7.20% at baseline, P < .001). Insulin users had consistently higher median hemoglobin A1C values compared with insulin nonusers (P < .001). Adverse events were experienced by 12 of 51 patients (23.5%), of which 4 cases (7.8%) were severe. CONCLUSIONS Proximal bowel bypass by DJBL is an effective tool for weight reduction and glycemic control. Metabolic achievements are partially preserved at 1 year after device removal. Because DJBL entails a considerable rate of side effects, strategies to mitigate them are warranted.
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Affiliation(s)
- Liat Deutsch
- Bariatric Endoscopy service, Gastroenterology and Liver Diseases Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Limor Ben Haim
- Endocrinology Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Yael Sofer
- Endocrinology Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Nathan Gluck
- Bariatric Endoscopy service, Gastroenterology and Liver Diseases Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Erwin Santo
- Bariatric Endoscopy service, Gastroenterology and Liver Diseases Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Sigal Fishman
- Bariatric Endoscopy service, Gastroenterology and Liver Diseases Department, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
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25
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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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26
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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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27
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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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28
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Cripps C, Roslin M. Endoluminal Treatments for Obesity and Related Hypertension: Updates, Review, and Clinical Perspective. Curr Hypertens Rep 2018; 18:79. [PMID: 27785714 DOI: 10.1007/s11906-016-0691-0] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
PURPOSE OF REVIEW Obesity is a global epidemic that continues to grow and results in related conditions such as hypertension and diabetes despite established interventions, thus suggesting the importance of new technologies. RECENT FINDINGS Endoscopic interventions are vast in scope and effectiveness. Intra-gastric balloons appear to dominate the field at this time, but a recent FDA-approved technique, the Aspire device, may soon cause a shift in the treatment paradigm. Short-term studies demonstrate optimistic results, yet long-term studies have not been performed. In addition, complications from these procedures are severe, resulting in significant morbidity when they occur. Treatment of bariatric surgery complications with endoscopic techniques is an expanding field that relies heavily on new innovation. The next few years in bariatric endoscopy promise to be turbulent and controversial. Endoscopic procedures for obesity will undoubtedly increase but are anticipated to do so at a slower rate than many projects. Bariatric surgery complications will continue to be treated by endoscopic means, and optimization of these procedures is on the horizon. This review will provide those who treat obesity-related hypertension on the current state of bariatric endoluminal procedures.
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29
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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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30
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Hurt RT, Frazier TH, Mundi MS. Novel Nonsurgical Endoscopic Approaches for the Treatment of Obesity. Nutr Clin Pract 2017. [PMID: 28622478 DOI: 10.1177/0884533617714235] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Globally, obesity is a leading cause of preventable death and is associated with >60 comorbid medical conditions, including 10 types of cancer that are strongly associated with body mass index. There are a number of traditional obesity treatments-for example, lifestyle management (eg, decreased caloric intake and increased expenditure), pharmacotherapy, and bariatric surgery. Recently, endoscopic approaches have emerged as a viable alternative for weight loss. Endoscopically placed intragastric balloons were introduced in the early 1980s for the treatment of medically complicated obesity but, unfortunately, had high rates of complications, such as premature deflation leading to obstruction. Despite these shortcomings, these devices have experienced a renewal, with a second generation of improved devices being approved for clinical use in 2015. In addition to the intragastric balloons, there are a number of other endoscopic approaches to weight loss that are either Food and Drug Administration approved or undergoing evaluation (aspiration therapy, duodenal jejunal bypass sleeve). The current review examines the literature available and discusses the practical clinical considerations involved.
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Affiliation(s)
- Ryan T Hurt
- 1 Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.,2 Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.,3 Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.,4 Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, Kentucky, USA
| | - Thomas H Frazier
- 4 Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, Kentucky, USA.,5 Three Rivers Medical Center, Louisa, Kentucky, USA
| | - Manpreet S Mundi
- 1 Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota, USA
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31
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Edmundowicz SA. Small Bowel Target Devices and Techniques. Gastrointest Endosc Clin N Am 2017; 27:289-297. [PMID: 28292407 DOI: 10.1016/j.giec.2017.01.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
The small bowel is a prime target for bariatric and metabolic endoscopic therapies. New insights into the mechanisms of action of surgical therapies have led to new endoscopic therapies for obesity, type 2 diabetes mellitus, and the metabolic syndrome. The development of endoluminal sleeves that bypass the proximal duodenum have replicated some of the effects of surgical bypass procedures. The endoscopic dual-path enteral bypass has created new and treatment options for these conditions. Duodenal mucosal resurfacing offers significant promise for diabetes management. It is hoped that a durable endoscopic therapy for these conditions will be defined and optimized.
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Affiliation(s)
- Steven A Edmundowicz
- Digestive Health Center, University of Colorado Hospital, University of Colorado School of Medicine, Mail Stop F735, Anschutz Outpatient Pavilion, 1635 Aurora Court, Aurora, CO 80045, USA.
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Klobucar Majanovic S, Brozovic B, Stimac D. Bariatric endoscopy: current state of the art, emerging technologies, and challenges. Expert Rev Med Devices 2017; 14:149-159. [PMID: 28081657 DOI: 10.1080/17434440.2017.1281741] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
Over the last few decades obesity has become a major health issue worldwide. Although dietary and lifestyle changes are the cornerstone of obesity management, it still poses a huge challenge for the majority of patients to permanently change their eating habits. Bariatric endoscopy represents an evolving filed of minimally invasive techniques and procedures for weight loss trying to respond to these challenges by developing new methods with the increasing role of endoscopists in the management of obesity. Areas covered: The aim of this article is to review the role and the advantages of bariatric endoscopy in the management of obesity by providing a comprehensive reference source and evaluating the currently available and emerging endoscopic devices and techniques for weight loss. Expert commentary: Endoscopic methods for weight loss represent a useful armamentarium in the management of obesity by providing improved effectiveness compared with medications, with a lower risk profile than traditional bariatric surgery. Although preliminary results of recently introduced methods are encouraging, many questions remain regarding the safety and efficacy of such interventions. Combining scientific background with advancements in technology is the key strategy for the further development of bariatric endoscopy.
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Affiliation(s)
- Sanja Klobucar Majanovic
- a Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolic Diseases , University Hospital Rijeka , Croatia , Rijeka
| | - Boris Brozovic
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
| | - Davor Stimac
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
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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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Park JM. Role of Malabsorptive Endoscopic Procedures in Obesity Treatment. Clin Endosc 2017; 50:26-30. [PMID: 28147470 PMCID: PMC5299975 DOI: 10.5946/ce.2017.004] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2016] [Revised: 01/08/2017] [Accepted: 01/15/2017] [Indexed: 11/21/2022] Open
Abstract
The incidence of obesity is increasing, and more definitive treatment modalities are needed. Endoluminal procedures, including restrictive endoscopic procedures, endoscopic gastroplasty, and malabsorptive endoscopic procedures, can reduce weight in obese patients and control obesity-related comorbidities. Malabsorptive endoscopic interventions also offer the potential for an ambulatory procedure that may be safer and more cost-effective compared with laparoscopic surgery. Malabsorptive endoscopic intervention can induce weight reduction and improve obesity-related metabolic parameters, despite complications such as device migration, obstruction, and abdominal pain. Improvement in technique will follow the development of new devices.
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Affiliation(s)
- Jae Myung Park
- Division of Gastroenterology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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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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36
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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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Abstract
Obesity remains a tremendous public health, clinical, and scientific challenge globally. Conventional approaches in the management of obesity offer limited potential for sustained weight loss. Bariatric surgery, although it represents the most effective weight loss treatment, has its own risks and is associated with substantial costs and limited patient applicability. Endoscopic weight loss procedures are considered as the major breakthrough in the management of obesity. Endoluminal interventions performed entirely through the gastrointestinal tract have evolved as a result of an attempt to replicate some of the anatomical features and the physiological effects of the traditional weight loss surgery while being reversible, less invasive, and more cost-effective. Restrictive procedures act to decrease gastric volume by space-occupying devices and/or by suturing or stapling techniques that alter gastric anatomy, whereas malabsorptive procedures tend to create malabsorption by preventing food contact with the duodenum and proximal jejunum. Other procedures act by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve blocking) or by gastric aspiration. It is important to underline that the majority of endoscopic weight loss procedures are still being evaluated and are not yet available routinely. Even though some of the techniques and devices that have recently emerged have demonstrated promising short-term results, evidence on their safety and long-term efficacy from well-designed and well-conducted research should be given before they can become an inherent part of everyday clinical practice. Given the rapid development of endoscopic weight loss procedures, this review considers the current state and recent trends in endoscopic management of obesity.
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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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Abstract
Obesity continues to be a growing epidemic worldwide. Although bariatric surgery remains the most effective and durable treatment of obesity and its comorbidities, there is a need for less invasive yet efficacious weight loss therapies. Currently the Food and Drug Administration has approved two endoscopically placed intragastric balloon devices and a surgically placed vagal blockade device. Another device that holds promise, particularly for the treatment of type 2 diabetes, is the endoscopically placed duodenojejunal bypass sleeve. This article reviews the indications and current data regarding results for these devices.
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Affiliation(s)
- Julietta Chang
- Digestive Diseases Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
| | - Stacy Brethauer
- Digestive Diseases Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA
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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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Abstract
The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.
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Affiliation(s)
- Kartik Sampath
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.
- Gastroenterology Fellow, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH, 03756, USA.
| | - Amreen M Dinani
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA
| | - Richard I Rothstein
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA
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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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Brethauer SA, Chang J, Galvao Neto M, Greve JW. Gastrointestinal devices for the treatment of type 2 diabetes. Surg Obes Relat Dis 2016; 12:1256-61. [PMID: 27568475 DOI: 10.1016/j.soard.2016.02.031] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2016] [Accepted: 02/23/2016] [Indexed: 01/07/2023]
Abstract
BACKGROUND Obesity and type 2 diabetes (T2D) continue to be growing epidemics worldwide. Although bariatric surgery remains the most effective and durable treatment for both of these chronic diseases, there is a need for therapies with risk and benefit profiles between medication and standard surgical procedures. Currently there are several endoscopic and minimally invasive therapies available worldwide to treat T2D. OBJECTIVE To review the current evidence regarding the safety and efficacy of medical devices to treat T2D. SETTING Academic practice, international METHODS The published literature was searched for articles evaluating the safety and efficacy of endoluminal and surgical devices used for the treatment of obesity and T2D. RESULTS The current devices in use include intragastric balloons, a duodenal-jejunal liner, gastric content aspiration, and devices that provide neuromodulation to the stomach or vagal nerves. On early phases of first-in-human studies is the duodenal mucosal resurfacing. The current evidence supporting the safety and efficacy of temporary use (6 months) for the intragastric balloon for lower body mass index (BMI) patients is strong and there is growing evidence regarding the effects of the other devices to treat T2D. CONCLUSIONS There is a need for novel therapies to bridge the risk and benefit gap between medical and surgical treatment of T2D. The original indication for many of the current devices was treatment of obesity. Several devices that are currently available are promising but require more study in T2D patient populations.
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Affiliation(s)
- Stacy A Brethauer
- Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio.
| | - Julietta Chang
- Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Manoel Galvao Neto
- Department of Surgery, Herbert Wertheim School of Medicine, Florida International University, Miami, Florida
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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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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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Endoscopic Bypass Using Endobarrier Devices: Efficacy in Treating Obesity and Metabolic Syndrome. J Clin Gastroenterol 2015; 49:799-803. [PMID: 26302497 DOI: 10.1097/mcg.0000000000000396] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
Obesity is a rapidly growing pandemic. Scope of pharmacotherapy and bariatric surgery in managing obesity is ever rising. The role of minimally invasive techniques to achieve preoperative weight loss and improve postbariatric surgery outcomes is an area of new interest. The initial experience with endobarrier devices in achieving weight loss among obese subjects has shown promising results. In addition, the impact of these interventions on comorbidities commonly associated with obesity like diabetes mellitus type 2 and hyperlipidemia has further expanded their potential for use in future. In this review article, we have summarized case report, prospective single and multicenter studies, and randomized-controlled trials describing the use of endobarrier devices. Indications, techniques, outcomes, limitations, and complications reported are discussed.
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ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015; 82:425-38.e5. [PMID: 26232362 DOI: 10.1016/j.gie.2015.03.1964] [Citation(s) in RCA: 285] [Impact Index Per Article: 28.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2015] [Accepted: 03/17/2015] [Indexed: 02/08/2023]
Abstract
The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.
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Kumbhari V, Oberbach A, Nimgaonkar A. Primary endoscopic therapies for obesity and metabolic diseases. Curr Opin Gastroenterol 2015; 31:351-8. [PMID: 26154430 DOI: 10.1097/mog.0000000000000203] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
PURPOSE OF REVIEW Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult population who would benefit from therapy for obesity but are not receiving it. Endoluminal approaches have the potential to be more efficacious than antiobesity medications and have a lower risk-cost profile compared with bariatric surgery. This review outlines the current state of primary endoscopic weight loss and metabolic therapies and sheds light on the challenges faced toward making endoscopic bariatric therapies 'ready for prime time'. RECENT FINDINGS Endoscopic approaches to obesity are being increasingly modeled on the proposed mechanisms contributing to the benefits of bariatric surgery.Therapies targeted at the stomach induce weight loss with only a proportional benefit to underlying metabolic disorders.Therapies targeting the proximal small bowel appear to modulate various neurohormonal pathways resulting in an improvement in metabolic profile in excess to that accounted for by weight loss itself. SUMMARY Rigorous scientific assessment of endoscopic approaches to obesity is necessary to allow its integration into the treatment algorithm of obesity. The endoscopic armamentarium against obesity continues to evolve with the endoscopist poised to be a key player in the management of this disease. VIDEO ABSTRACT http://links.lww.com/COG/A12.
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Affiliation(s)
- Vivek Kumbhari
- aDepartment of Medicine and Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA bDepartment of Cardiac Surgery, University Leipzig Heart Center Leipzig, Leipzig, Germany
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Abstract
Type 2 diabetes mellitus (T2DM) and obesity are increasingly common and major global health problems. The Edmonton obesity staging system clearly pointed towards increased mortality proportionate to the severity of obesity. Obesity itself triggers insulin resistance and thereby poses the risk of T2DM. Both obesity and T2DM have been associated with higher morbidity and mortality and this calls for institution of effective therapies to deal with the rising trend of complications arising out of this dual menace. Although lifestyle changes form the cornerstone of therapy for both the ailments, sustained results from this modalities is far from satisfactory. While Look AHEAD (action for HEAalth in diabetes) study showed significant weight loss, reduction in glycated hemoglobin and higher remission rate of T2DM at 1(st) year following intensive lifestyle measures; recurrence and relapse rate bounced back in half of subjects at 4 years, thereby indicating that weight loss and glycemic control is difficult to maintain in the long term with lifestyle interventions. Same recurrence phenomenon was also observed with pharmacotherapy with rimonabant, sibutramine and orlistat. Bariatric surgery has been seen to associate with substantial and sustained weight loss in morbidly obese patients. Interestingly, bariatric surgeries also induce higher rates of short and long-term diabetes remission. Although the exact mechanism behinds this diabetes remission are not well understood; improved insulin action, beta-cell function and complex interplay of hormones in the entero-insular axis appears to play a major role. This article reviews the effectiveness of bariatric procedures on remission or improvement in diabetes and put a perspective on its implicated mechanisms.
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Affiliation(s)
- Awadhesh Kumar Singh
- Department of Consultant Endocrinologist, G.D Hospital and Diabetes Institute, Kolkata, West Bengal, India
| | - Ritu Singh
- Consultant Gynecologist, G.D Hospital and Diabetes Institute, Kolkata, West Bengal, India
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