Ghrelin and Insulin Resistance

Vanderbilt University Medical Center

Status and phase: Completed; Phase 1

Conditions: Normal Weight,Healthy Controls; Insulin Resistance; Obesity

Treatments: Drug: Ghrelin infusion to assess effects on insulin sensitivity

Study type: Interventional

Funder types: Other

Identifiers

NCT00884494

IRB#090362

NIH: RO1-DK070860-01S1

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Roux-en-Y gastric bypass

Experimental group

Treatment:

Drug: Ghrelin infusion to assess effects on insulin sensitivity

Lean

Experimental group

Treatment:

Drug: Ghrelin infusion to assess effects on insulin sensitivity