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Ghrelin and Insulin Resistance

This study has been completed.
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University Medical Center Identifier:
First received: April 16, 2009
Last updated: January 18, 2017
Last verified: January 2017
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
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: 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 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


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

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
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Please refer to this study by its identifier: NCT00884494

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
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 Identifier (NCT Number):
Responsible Party: Robyn Tamboli, Research Associate Professor, Vanderbilt University Medical Center Identifier: NCT00884494     History of Changes
Other Study ID Numbers: IRB#090362
NIH: RO1-DK070860-01S1
Study First Received: April 16, 2009
Last Updated: January 18, 2017

Keywords provided by Vanderbilt University Medical Center:
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017