Severe Obesity Clinical Trial
Official title:
Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
NCT number | NCT02340247 |
Other study ID # | SN-GALDE-14 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | January 13, 2015 |
Last updated | June 29, 2016 |
Start date | November 2014 |
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
Status | Completed |
Enrollment | 11 |
Est. completion date | |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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). |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre University Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GLP-1 secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | C-peptide secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | PYY secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | Glucagon secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | GIP secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | CCK secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | Gherlin secretion (evaluated by iAUC) | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | Changes in bile acids/FGF-19 | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | No | |
Secondary | TSH/T3/T4 | 0, 60, 120, 180 | No | |
Secondary | Appetite measurements (VAS-score) | Baseline, 30, 60, 120, 180 | No |
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