Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
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).
⁃ 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