The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Early Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Exendin 9,39Drug: Placebo
- Registration Number
- NCT01843855
- Lead Sponsor
- Adrian Vella
- Brief Summary
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
- Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).
Exclusion Criteria
- Subjects taking thiazolidinediones
- Subjects with active systemic illness
- Subjects with active microvascular or macrovascular complications of their diabetes
- For female subject: positive pregnancy test at the time of enrollment in study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exendin 9,39 Exendin 9,39 Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes. Placebo Placebo Subjects randomized to this arm will receive a saline infusion for 360 minutes.
- Primary Outcome Measures
Name Time Method Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) baseline, 4 weeks post-operative intervention The total disposition index equals the product of insulin secretion and insulin sensitivity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States