The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
|ClinicalTrials.gov Identifier: NCT01843855|
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Exendin 9,39 Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2013|
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.
- Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) [ Time Frame: baseline, 4 weeks post-operative intervention ]The total disposition index equals the product of insulin secretion and insulin sensitivity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843855
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905-0001|
|Principal Investigator:||Adrian Vella, M.D.||Mayo Clinic|