The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass|
- Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline) [ Time Frame: Day 1, Day 2 (approximately 2 weeks after day 1) ] [ Designated as safety issue: No ]The total disposition index equals the product of insulin secretion and insulin sensitivity.
|Study Start Date:||March 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Exendin 9, 39
Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.
Drug: Exendin 9, 39
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
Placebo Comparator: Placebo
A saline infusion will be administered in either first intervention period or second intervention period.
A saline infusion will be given to match the study drug infusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843881
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Adrian Vella, M.D.||Mayo Clinic|