Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Recruiting now · Early Phase 1

Conditions studied: Bariatric Surgery Candidate, Bile Acid, Elevated Serum, Glucose Metabolism Disorders

In brief

Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).

Key facts

Study ID

NCT06925997

Run by

Hvidovre University Hospital

People needed

18

Starts

2024-05-02

Expected to finish

2028-12-01

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Intervention group
• RYGB-operated ≥ 18 months prior to inclusion
• History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
• HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
• Weight change < ±3 kg for >3 months at time of inclusion
• Control group A
• No history of diabetes
• HbA1c <48 mmol/mol at time of inclusion
• Fasting plasma glucose < 7.0 mmol/L at time of inclusion
• Weight change < ±3 kg for >3 months at time of inclusion Control group B
• Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
• Weight change < ±3 kg for >3 months at time of inclusion

You may not qualify if…

• Pregnancy or breastfeeding
• Haemoglobin < 6.5 mmol/L at time of inclusion
• Fasting plasma glucose > 10.0 mmol/L at time of inclusion
• Prior cholecystectomy
• Chronic or tendency to diarrhoea

Where it is running

• Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre — Hvidovre, Denmark (enrolling)

Full record on ClinicalTrials.gov

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