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Ghrelin and Insulin Resistance

Primary Purpose

Obesity, Insulin Resistance, Normal Weight,Healthy Controls

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ghrelin infusion to assess effects on insulin sensitivity
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Insulin resistance, Ghrelin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Roux-en-Y gastric bypass

Lean

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2009
Last Updated
January 18, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00884494
Brief Title
Ghrelin and Insulin Resistance
Official Title
Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Normal Weight,Healthy Controls
Keywords
Obesity, Insulin resistance, Ghrelin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roux-en-Y gastric bypass
Arm Type
Experimental
Arm Title
Lean
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ghrelin infusion to assess effects on insulin sensitivity
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Tamboli, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naji Abumrad, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26599819
Citation
Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
Results Reference
derived

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Ghrelin and Insulin Resistance

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