The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|