Ghrelin and Insulin Resistance

Obesity Clinical Trial

Official title:

Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884494
• Other study ID #: IRB#090362
• Secondary ID: NIH: RO1-DK07086
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2009
• Last updated: January 18, 2017
• Start date: August 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Normal Weight,Healthy Controls
• Obesity

Intervention

Drug:
• Ghrelin infusion to assess effects on insulin sensitivity

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.		1 year