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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:
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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Investigators
Principal Investigator: Adrian Vella, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Adrian Vella, Consultant, Endocrinology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01843881     History of Changes
Other Study ID Numbers: 11-007667, R01DK082396, UL1RR024150
Study First Received: April 26, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Gastric Bypass
bariatric surgery
carbohydrate metabolism

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

ClinicalTrials.gov processed this record on November 20, 2014