The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass|
- Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) [ Time Frame: baseline, 4 weeks post-operative intervention ] [ Designated as safety issue: No ]The total disposition index equals the product of insulin secretion and insulin sensitivity.
|Study Start Date:||June 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Exendin 9,39
Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.
Drug: Exendin 9,39
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
Placebo Comparator: Placebo
Subjects randomized to this arm will receive a saline infusion for 360 minutes.
A saline infusion will be given to match the study drug infusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843855
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905-0001|
|Principal Investigator:||Adrian Vella, M.D.||Mayo Clinic|