Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Launched by HVIDOVRE UNIVERSITY HOSPITAL · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how bile acids in the body affect metabolism, particularly after gastric bypass surgery, a procedure often used for weight loss in people with obesity. The researchers want to understand how these bile acids impact a specific hormone called fibroblast growth factor-19 (FGF-19) and how they relate to blood sugar control. The study involves two groups: one group consists of individuals who had gastric bypass surgery and have a history of diabetes, while the other groups include people with and without diabetes who meet specific health criteria.

To participate in this trial, you need to be at least 18 years old and have had gastric bypass surgery at least 18 months ago if you're in the diabetes group. If you're in the control groups, you should not have a history of diabetes or should meet certain blood sugar levels. Participants can expect to take an experimental medication called colesevelam, which helps remove bile acids from the body, and to undergo various health assessments throughout the study. It's important to know that this trial is open to both men and women, and they are currently recruiting participants. If you meet the eligibility criteria and are interested, this could be an opportunity to contribute to valuable research on metabolic health after weight loss surgery.

Gender

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Eligibility 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