Actively Recruiting
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Led by Hvidovre University Hospital · Updated on 2025-04-13
18
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For the intervention group: Roux-en-Y gastric bypass surgery at least 18 months before joining
- History of diabetes before gastric bypass, or HbA1c less than 58 mmol/mol on no antidiabetic medication or metformin alone
- Weight change less than plus or minus 3 kilograms for over 3 months at inclusion
- For control group A: No history of diabetes, HbA1c less than 48 mmol/mol, fasting plasma glucose below 7.0 mmol/L, and stable weight
- For control group B: Type 2 diabetes with HbA1c 48 mmol/mol or higher or on antidiabetic medication, and stable weight
You will not qualify if you...
- Pregnancy or breastfeeding
- Hemoglobin less than 6.5 mmol/L at inclusion
- Fasting plasma glucose over 10.0 mmol/L at inclusion
- Previous gallbladder removal (cholecystectomy)
- Chronic diarrhea or tendency to diarrhea
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
M
Marie-Louise Dichman
CONTACT
C
Carsten Dirksen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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