Bolado F, Zabalza L, de-Carlos J, Tamayo-Rodríguez I, Prieto-Martínez C, Hervás-Palacios N. Longitudinal assessment of pancreatic exocrine dysfunction in type 1 diabetes. World J Diabetes 2025; 16(12): 112799 [DOI: 10.4239/wjd.v16.i12.112799]
Corresponding Author of This Article
Federico Bolado, MD, PhD, Associate Professor, Department of Gastroenterology, Hospital Universitario de Navarra, Calle Irunlarrea 3, Pamplona 31003, Navarre, Spain. federico.bolado@unavarra.es
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Gastroenterology & Hepatology
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Prospective Study
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Dec 15, 2025 (publication date) through Dec 15, 2025
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World Journal of Diabetes
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1948-9358
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Bolado F, Zabalza L, de-Carlos J, Tamayo-Rodríguez I, Prieto-Martínez C, Hervás-Palacios N. Longitudinal assessment of pancreatic exocrine dysfunction in type 1 diabetes. World J Diabetes 2025; 16(12): 112799 [DOI: 10.4239/wjd.v16.i12.112799]
World J Diabetes. Dec 15, 2025; 16(12): 112799 Published online Dec 15, 2025. doi: 10.4239/wjd.v16.i12.112799
Longitudinal assessment of pancreatic exocrine dysfunction in type 1 diabetes
Federico Bolado, Lucía Zabalza, Joaquín de-Carlos, Ibai Tamayo-Rodríguez, Carlos Prieto-Martínez, Nerea Hervás-Palacios
Federico Bolado, Lucía Zabalza, Carlos Prieto-Martínez, Nerea Hervás-Palacios, Department of Gastroenterology, Hospital Universitario de Navarra, Pamplona 31003, Navarre, Spain
Federico Bolado, Joaquín de-Carlos, Ibai Tamayo-Rodríguez, Navarrabiomed, Instituto de Investigación Sanitaria de Navarra, Pamplona 31008, Navarre, Spain
Federico Bolado, Department of Medicine, Universidad Pública de Navarra, Pamplona 31008, Navarre, Spain
Joaquín de-Carlos, Department of Endocrinology, Hospital Universitario de Navarra, Pamplona 31003, Navarre, Spain
Author contributions: Bolado F provided the study design; Bolado F and Prieto-Martínez C participated in the first phase of the study, including data collection and processing; Zabalza L and de-Carlos J were primarily involved in the second phase of the study; Tamayo-Rodríguez I supervised the methodology, and followed and performed statistical analysis; Hervás-Palacios N performed a thorough literature review, and contributed to project coordination; all authors contributed to the drafting of the manuscript and approved the final version.
Institutional review board statement: The study was approved by the Institutional Review Board (Comité Ético de Experimentación Clínica de Navarra: PI_2013/8) and was conducted in accordance with the ethical guidelines of the 1975 Declaration of Helsinki. As it consisted of two phases, separate written informed consent was obtained from all participants prior to each phase.
Informed consent statement: All participants provided informed consent prior to inclusion in the study. Oral and written information about the study objectives and procedures was given to each participant, and written consent was obtained separately for both study phases.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request to fboladoc@cfnavarra.es.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Federico Bolado, MD, PhD, Associate Professor, Department of Gastroenterology, Hospital Universitario de Navarra, Calle Irunlarrea 3, Pamplona 31003, Navarre, Spain. federico.bolado@unavarra.es
Received: August 22, 2025 Revised: September 16, 2025 Accepted: November 5, 2025 Published online: December 15, 2025 Processing time: 115 Days and 17.9 Hours
Abstract
BACKGROUND
Previous studies have shown that individuals with type 1 diabetes (T1D) frequently present with reduced fecal elastase levels, suggesting exocrine pancreatic insufficiency. However, the underlying determinants and the longitudinal trajectory of these changes remain poorly understood.
AIM
To evaluate longitudinal changes in fecal elastase among individuals with T1D, identify associated factors, and determine clinical implications.
METHODS
Pancreatic exocrine function was evaluated in a cohort of patients with T1D by measuring fecal elastase concentrations (FECs). After a mean follow-up of 8.5 ± 0.5 years, participants were recontacted, and a second stool sample was obtained. At both time points, detailed medical histories were collected, including information on diabetes progression, metabolic control, complications, gastrointestinal symptoms, and nutritional status. The study was approved by the institutional ethics committee, and written informed consent was obtained from all participants.
RESULTS
A total of 106 individuals with T1D (mean age = 46.2 years; 50% male) were enrolled. At baseline, the median FEC was 239.5 µg/g, with 44 participants (41.5%) demonstrating abnormally low levels (< 200 µg/g). Reduced fecal elastase was significantly associated with male sex, diabetes-related complications, particularly retinopathy, and higher glycated hemoglobin levels. No significant differences in gastrointestinal symptoms, body mass index, nor most serum nutritional markers were observed between individuals with normal vs reduced fecal elastase levels. Sixty-six participants completed follow-up. Their median fecal elastase was 171.5 µg/g, with 59.1% presenting levels below 200 µg/g. Paired analysis showed a non-significant decline in FEC s over time. No clinical nor metabolic variables predicted longitudinal changes in FEC independently.
CONCLUSION
Fecal elastase levels are frequently reduced in individuals with T1D and may show a gradual decline over time. The clinical impact of these changes appears to be limited.
Core Tip: This is the first study to investigate exocrine pancreatic dysfunction in individuals with type 1 diabetes (T1D) using fecal elastase in a longitudinal design. Our findings suggest that pancreatic exocrine function is frequently altered in T1D and may decline over time. However, the underlying pathophysiology remains unclear, and the clinical impact appears limited. Therefore, low fecal elastase levels in T1D should be interpreted with caution to avoid overdiagnosis and unnecessary treatment.
