Ghrelin and Insulin Resistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Insulin Resistance Normal Weight,Healthy Controls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Roux-en-Y gastric bypass

Group Type EXPERIMENTAL

Ghrelin infusion to assess effects on insulin sensitivity

Intervention Type DRUG

Lean

Group Type EXPERIMENTAL

Ghrelin infusion to assess effects on insulin sensitivity

Intervention Type DRUG

Interventions

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Ghrelin infusion to assess effects on insulin sensitivity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-65
* BMI \> 35 kg/m2
* Scheduled for bariatric surgery at Vanderbilt University Medical Center

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes