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Ghrelin and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00884494
First Posted: April 20, 2009
Last Update Posted: January 20, 2017
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.
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University Medical Center
  Purpose
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.

Condition Intervention Phase
Obesity Insulin Resistance Normal Weight,Healthy Controls Drug: Ghrelin infusion to assess effects on insulin sensitivity Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Robyn Tamboli, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period. [ Time Frame: 1 year ]

Enrollment: 20
Study Start Date: August 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roux-en-Y gastric bypass Drug: Ghrelin infusion to assess effects on insulin sensitivity
Experimental: Lean Drug: Ghrelin infusion to assess effects on insulin sensitivity

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for RYGB group:

  • Age 18-65
  • BMI > 35 kg/m2
  • Scheduled for bariatric surgery at Vanderbilt University Medical Center

Inclusion Criteria for Lean group:

  • Age 18-65
  • BMI < 30kg/m2

Exclusion Criteria:

  • Prior bariatric surgery
  • Serum creatinine > 1.5 mg/dl
  • Hepatic enzyme elevations > 2x upper limits of normal
  • Current use of warfarin or clopidogrel
  • Intercurrent infections
  • Females with positive pregnancy test
  • Abnormal ECG
  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): NCT00884494


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Robyn Tamboli, PhD Vanderbilt University Medical Center
Study Director: Naji Abumrad, MD Vanderbilt University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robyn Tamboli, Research Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00884494     History of Changes
Other Study ID Numbers: IRB#090362
NIH: RO1-DK070860-01S1
First Submitted: April 16, 2009
First Posted: April 20, 2009
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Robyn Tamboli, Vanderbilt University Medical Center:
Obesity
Insulin resistance
Ghrelin

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs