Status:
RECRUITING
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Bariatric Surgery Candidate
Bile Acid, Elevated Serum
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 d...
Detailed Description
The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatme...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06925997
Start Date
May 2 2024
End Date
December 1 2028
Last Update
April 13 2025
Active Locations (1)
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1
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark, 2650