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Completed

NCT Number: NCT00884494

Ghrelin and Insulin Resistance

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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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Normal Weight,Healthy Controls Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ghrelin infusion to assess effects on insulin sensitivity

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2009
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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