Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Overview
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
Full Title of Study: “Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: April 2015
Interventions
- Other: Water
- Drug: Ursodeoxycholic Acid
- Drug: Chenodeoxycholic Acid
Arms, Groups and Cohorts
- Experimental: Placebo
- 150mL water
- Experimental: Ursodeoxycholic acid
- Ursodeoxycholic acid (750mg) dissolved in 150mL water
- Experimental: Chenodeoxycholic acid
- Chenodeoxycholic acid (1250mg) dissolved in 150mL water
Clinical Trial Outcome Measures
Primary Measures
- GLP-1 secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Secondary Measures
- C-peptide secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- PYY secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- Glucagon secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- GIP secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- CCK secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- Gherlin secretion (evaluated by iAUC)
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- Changes in bile acids/FGF-19
- Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
- TSH/T3/T4
- Time Frame: 0, 60, 120, 180
- Appetite measurements (VAS-score)
- Time Frame: Baseline, 30, 60, 120, 180
Participating in This Clinical Trial
Inclusion Criteria
- Uncomplicated RYGB performed minimum 3 months prior to the study. – Fasting plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB. Exclusion Criteria:
- Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB. – Dysregulated hypothyroidism, use of antithyroid treatment. – Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis. – Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hvidovre University Hospital
- Collaborator
- University of Copenhagen
- Provider of Information About this Clinical Study
- Principal Investigator: Maria Saur Svane, MD – Hvidovre University Hospital
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