Effects of bile acids on glucose metabolism after gastric bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.