Severe Obesity Clinical Trial
Official title:
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Verified date | November 2020 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.
Status | Completed |
Enrollment | 8 |
Est. completion date | November 2020 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Uncomplicated RYGB performed minimum 3 months prior to the study. - Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB Exclusion Criteria: - Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB - Dysregulated thyroid diseases, 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) - Cholecystectomy. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre University Hospital | Hvidovre | DK |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GLP-1 secretion (evaluated by iAUC) | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake. | ||
Secondary | Glucose levels | -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | PYY secretion | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Glucagon secretion | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | GIP secretion | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Insulin secretion | -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | C-peptide secretion | -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | CCK secretion | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Total ghrelin | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Total bile acid secretion | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Bile acids fractions / FGF-19 concentrations | -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes | ||
Secondary | Appetite measurements (VAS-score) | -10, 30, 60, 120, 180 and 240 minutes |
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