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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exendin 9,39 Drug: Placebo Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Primary Completion Date : July 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Placebo
A saline infusion will be given to match the study drug infusion.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
Sponsors and Collaborators
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
More Information

Responsible Party: Adrian Vella, Consultant, Endocrinology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01843855     History of Changes
Other Study ID Numbers: 11-000161
R01DK082396 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Adrian Vella, Mayo Clinic:
Gastric Bypass
bariatric surgery
glucose metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents