This trial is active, not recruiting.

Conditions obesity, insulin resistance, normal weight,healthy controls
Treatment ghrelin infusion to assess effects on insulin sensitivity
Sponsor Vanderbilt University
Start date August 2011
End date December 2016
Trial size 20 participants
Trial identifier NCT00884494, IRB#090362, NIH: RO1-DK070860-01S1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Ghrelin infusion to assess effects on insulin sensitivity
ghrelin infusion to assess effects on insulin sensitivity
Normal weight, healthy adults to act as controls
ghrelin infusion to assess effects on insulin sensitivity

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
Principal investigator Robyn Tamboli, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.