The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01843855
First received: April 26, 2013
Last updated: December 3, 2013
Last verified: December 2013

April 26, 2013
December 3, 2013
June 2011
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01843855 on ClinicalTrials.gov Archive Site
Not Provided
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The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Exendin 9,39
    Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
  • Drug: Placebo
    A saline infusion will be given to match the study drug infusion.
  • Experimental: Exendin 9,39
    Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.
    Intervention: Drug: Exendin 9,39
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive a saline infusion for 360 minutes.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01843855
11-000161, R01DK082396, UL1RR024150
No
Adrian Vella, Mayo Clinic
Adrian Vella
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Center for Research Resources (NCRR)
Principal Investigator: Adrian Vella, M.D. Mayo Clinic
Mayo Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP