Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHvidovre University Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Colesevelam
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov