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The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843881
First Posted: May 1, 2013
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic
April 26, 2013
May 1, 2013
December 4, 2013
March 2012
September 2013   (Final data collection date for primary outcome measure)
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) ]
The total disposition index equals the product of insulin secretion and insulin sensitivity.
Same as current
Complete list of historical versions of study NCT01843881 on ClinicalTrials.gov Archive Site
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The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
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.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
    Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.
    Intervention: Drug: Exendin 9, 39
  • Placebo Comparator: Placebo
    A saline infusion will be administered in either first intervention period or second intervention period.
    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
20
December 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects:

  • Subjects who have undergone RYGB

Inclusion Criteria Healthy Subjects:

  • Must match RYGB subjects in age, weight, and gender
  • Subjects will be without active systemic illness

Exclusion Criteria all Subjects:

  • Subjects <20 years old and >70 years old
  • For Female Subjects: positive pregnancy text at the time of enrollment or study
  • Subjects with functional or organic bowel symptoms.
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01843881
11-007667
R01DK082396 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
No
Not Provided
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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