RecruitingEarly Phase 1NCT06925997

Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Sponsor

Hvidovre University Hospital

Enrollment

18 participants

Start Date

May 2, 2024

Study Type

INTERVENTIONAL

Conditions

Bariatric Surgery Candidate Glucose Metabolism Disorders Bile Acid, Elevated Serum

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

Min Age: 18 Years

Inclusion Criteria12

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 Criteria5

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

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Interventions

DRUGColesevelam

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.