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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:
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
ClinicalTrials.gov Identifier:
NCT01843881
First received: April 26, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose
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.

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: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Contribution of Incretin Hormones to Post-prandial 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 (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.


Enrollment: 20
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exendin 9, 39
Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.
Drug: Exendin 9, 39
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
Placebo Comparator: Placebo
A saline infusion will be administered in either first intervention period or second intervention period.
Drug: Placebo
A saline infusion will be given to match the study drug infusion.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843881

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
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: NCT01843881     History of Changes
Other Study ID Numbers: 11-007667
R01DK082396 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
Study First Received: April 26, 2013
Last Updated: December 3, 2013

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

ClinicalTrials.gov processed this record on September 21, 2017