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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
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 Criteria:
* 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
Primary outcome measure(s)
Glucose — 8 weeks Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
FGF-19 — 8 weeks Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Trial sites (1)
Facility
City
Region
Status
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre
Denmark
Recruiting
More Hvidovre University Hospital trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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