Effects of bile acids on glucose metabolism after gastric bypass surgery
Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
This study is testing how bile acids affect blood sugar levels in people who have had gastric bypass surgery by giving some participants a medication and comparing their results to others.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06925997 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates how endogenous bile acids influence glucose metabolism in patients who have undergone gastric bypass surgery. It involves a non-randomized, open-label design with two groups: an intervention group receiving colesevelam treatment and control groups for baseline comparisons. Participants will undergo multiple study visits, including blood tests and a mixed meal test, to assess changes in plasma fibroblast growth factor-19 (FGF-19) and glucose levels over an 8-week period. The study aims to better understand the metabolic effects of bile acids in this patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals who have undergone gastric bypass surgery at least 18 months prior and have a history of diabetes.
Not a fit: Patients who are pregnant, breastfeeding, or have certain blood glucose levels or prior cholecystectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of glucose metabolism disorders in patients post-gastric bypass surgery.
How similar studies have performed: While this approach is novel in the context of gastric bypass surgery, similar studies on bile acids and glucose metabolism have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hvidovre
- Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Study coordinator: Marie-Louise Dichman
- Email: marie-louise.dichman@regionh.dk
- Phone: +4526710371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.