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Ghrelin and Insulin Resistance

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00884494
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
33
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ghrelin infusion to assess effects on insulin sensitivity
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robyn Tamboli, Research Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00884494
Other Study ID Numbers:
  • IRB#090362
  • NIH: RO1-DK070860-01S1
First Posted:
Apr 20, 2009
Last Update Posted:
Jan 20, 2017
Last Verified:
Jan 1, 2017
Keywords provided by Robyn Tamboli, Research Associate Professor, Vanderbilt University Medical Center
Obesity
Insulin resistance
Ghrelin
Additional relevant MeSH terms:
Insulin Resistance
Insulin

Study Results

No Results Posted as of Jan 20, 2017