Ghrelin and Insulin Resistance

Phase 1

Completed

• Conditions: Insulin Resistance; Normal Weight,Healthy Controls; Obesity
• Interventions: Drug: Ghrelin infusion to assess effects on insulin sensitivity

• Registration Number: NCT00884494
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-20
• Study Start: 2011-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lean	Ghrelin infusion to assess effects on insulin sensitivity	-
Roux-en-Y gastric bypass	Ghrelin infusion to assess effects on insulin sensitivity	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.	1 year

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States