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Ghrelin and Insulin Resistance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00884494
First received: April 16, 2009
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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
Obesity
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, DNA


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Control
Normal weight, healthy adults to act as controls
 Drug: Ghrelin infusion to assess effects on insulin sensitivity

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884494

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

No publications provided

Responsible Party: Robyn Tamboli, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00884494     History of Changes
Other Study ID Numbers: IRB#090362, NIH: RO1-DK070860-01S1
Study First Received: April 16, 2009
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Obesity
Insulin resistance
Ghrelin

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013