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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843855
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
  Purpose
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 Intervention Phase
Type 2 Diabetes Mellitus Drug: Exendin 9,39 Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Adrian Vella, Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
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)
Investigators
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 Submitted: April 26, 2013
First Posted: May 1, 2013
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
Hormones
Gastric Inhibitory Polypeptide
Incretins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents