Ghrelin and Insulin Resistance

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University Identifier:
First received: April 16, 2009
Last updated: September 12, 2016
Last verified: September 2016
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
Insulin Resistance
Normal Weight,Healthy Controls
Drug: Ghrelin infusion to assess effects on insulin sensitivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

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 ]

Biospecimen Retention:   Samples With DNA
Plasma, DNA

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Roux-en-Y gastric bypass, ghrelin infusion
Ghrelin infusion to assess effects on insulin sensitivity
Drug: Ghrelin infusion to assess effects on insulin sensitivity
Normal weight, healthy adults to act as controls
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
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from the Center for Surgical Weight loss at Vanderbilt University Medical Center (Nashville, TN) after approval for Roux-en-Y gastric bypass surgery. Control participants will be recruited via advertisements

Inclusion Criteria:

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

Inclusion for Control 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
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 identifier: NCT00884494

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
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 Assistant Professor, Vanderbilt University Identifier: NCT00884494     History of Changes
Other Study ID Numbers: IRB#090362  NIH: RO1-DK070860-01S1 
Study First Received: April 16, 2009
Last Updated: September 12, 2016

Keywords provided by Vanderbilt University:
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 January 19, 2017