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Ghrelin and Insulin Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00884494
First received: April 16, 2009
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Obesity
Insulin Resistance
Normal Weight,Healthy Controls
Drug: Ghrelin infusion to assess effects on insulin sensitivity
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Basic Science
Official Title: Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: August 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roux-en-Y gastric bypass Drug: Ghrelin infusion to assess effects on insulin sensitivity
Experimental: Lean Drug: Ghrelin infusion to assess effects on insulin sensitivity

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884494

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Robyn Tamboli, PhD Vanderbilt University Medical Center
Study Director: Naji Abumrad, MD Vanderbilt University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robyn Tamboli, Research Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00884494     History of Changes
Other Study ID Numbers: IRB#090362  NIH: RO1-DK070860-01S1 
Study First Received: April 16, 2009
Last Updated: January 18, 2017

Keywords provided by Vanderbilt University Medical Center:
Obesity
Insulin resistance
Ghrelin

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017