Biliary effects of liraglutide and sitagliptin, a 12‐week randomized placebo‐controlled trial in type 2 diabetes patients
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AIMS: Treatment with glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors might increase gallstone formation; however, the mechanisms involved are unknown. We aimed to assess the effects of these drugs on gallbladder volume and bile acid profile. MATERIALS AND METHODS: ; HbA1c, 7.3% ± 0.6%), treated with metformin and/or sulfonylureas, were included in this 12-week randomized, placebo-controlled, double-blind, single-centre trial between July 2013 and August 2015 at the VU University Medical Center, the Netherlands. Patients received the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebo for 12 weeks. Gallbladder fasting volume and ejection fraction were measured using ultrasonography after a high-fat meal. Serum bile acids were measured in the fasting and postprandial state and in faecal samples. The trial was registered at ClinicalTrials.gov (NCT01744236). RESULTS: Neither liraglutide nor sitagliptin had an effect on gallbladder fasting volume and ejection fraction (p > .05). Liraglutide increased serum levels of deoxycholic acid in the fasting state [0.20 µmol/L (95% CI 0.027-0.376), p = 0.024] and postprandial state [AUC 40.71 (13.22-68.21), p = 0.005] and in faeces [ratio 1.5 (1.03-2.19); p = 0.035]. Sitagliptin had no effect on serum bile acids, but increased faecal levels of chenodeoxycholic acid [ratio 3.42 (1.33-8.79), p = 0.012], cholic acid [ratio 3.32 (1.26-8.87), p = 0.017] and ursodeoxycholic acid [ratio 3.81 (1.44-10.14), p = 0.008]. CONCLUSIONS: Neither liraglutide nor sitagliptin has an effect on gallbladder volume. Observed changes in bile acids with liraglutide suggest alterations in the intestinal microbiome, while sitagliptin appears to increase hepatic bile acid production.
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After 12-week liraglutide intervention, the authors were unable to demonstrate an effect on gallbladder emptying.
“after 12-week liraglutide intervention, we were unable to demonstrate an effect on gallbladder emptying”
From Safety of Semaglutide (2021) · cites this paper as [93]
The authors observed changes in deoxycholic acid levels in plasma and fecal samples after liraglutide treatment, but the clinical relevance remains unclear.
“While we observed changes in deoxycholic acid levels in plasma and fecal samples after liraglutide treatment, the clinical relevance remains unclear”
From Safety of Semaglutide (2021) · cites this paper as [93]
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Chiu, C.-T., Hu, Y., & Chang, C. (2026) · SAGE Open Medical Case Reports · doi:10.1177/2050313x261463142
Vadner, D. J., Brown, A. N., & Gold, M. H. (2026) · Dermatological Reviews · doi:10.1002/der2.70092
Insights from multi-omics on GLP-1 receptor agonists in type 2 diabetes and obesity
Elashi, A. A., Hedaya, L., Maggio, V., Naja, K., Rizzo, M., & Elrayess, M. A. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1812193
- Authors
- Smits, M. M., Tonneijck, L., Muskiet, M. H. A., Hoekstra, T., Kramer, M. H. H., Diamant, M., Nieuwdorp, M., Groen, A. K., Cahen, D. L., & van Raalte, D. H.
- Affiliations
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Amsterdam Public Health (NL)
- Department of Internal Medicine, Diabetes Center VU University Medical Center Amsterdam the Netherlands
- Amsterdam UMC Location University of Amsterdam (NL)
- University Medical Center Groningen (NL)
- Erasmus MC (NL)
- Corresponding author
- Smits, Mark M.
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2016-08-30
- Volume
- 18
- Issue
- 12
- Pages
- 1217-1225
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC5129471
- OpenAlex
- W2498502918
- Cited by
- 56
- References
- 31
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 2 · 2023: 3 · 2022: 6 · 2021: 8 · 2020: 4 · 2019: 6 · 2018: 7 · 2017: 7
- FWCI
- 6.70
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
- RePub (Erasmus University Rotterdam) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Seventh Framework Programme (FP7/2007‐2013, n° 282521)
- AstraZeneca
- Boehringer Ingelheim
- Novo Nordisk
- Sanofi
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gallbladder and Bile Duct Disorders
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- sitagliptin, type 2 diabetes, gallstone formation, gallbladder volume, gallbladder ejection fraction, bile acids, deoxycholic acid, chenodeoxycholic acid, cholic acid, ursodeoxycholic acid, fecal bile acids, GLP-1 receptor agonists, DPP-4 inhibitors
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Sitagliptin Phosphate, Liraglutide, Glucagon-Like Peptide-1 Receptor Agonists, Aged, Bile Acids and Salts, Blood Glucose, Chenodeoxycholic Acid, Deoxycholic Acid, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Fasting, Feces, Female, Gallbladder, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Organ Size, Sulfonylurea Compounds, Ultrasonography, Ursodeoxycholic Acid, Postprandial Period, Cholic Acid, Dipeptidyl-Peptidase IV Inhibitors
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