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RECRUITING
NCT06925997
EARLY_PHASE1

Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Sponsor: Hvidovre University Hospital

View on ClinicalTrials.gov

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 depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-05-02

Completion Date

2028-12

Last Updated

2025-04-13

Healthy Volunteers

Yes

Interventions

DRUG

Colesevelam

Colesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (\>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants.

Locations (1)

Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, Denmark