Back to resultsGhrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Primary Purpose
Obesity, Insulin Resistance
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo
pioglitazone
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring obesity
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 80, weight stable for at least 3 months
At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:
- fasting plasma glucose level of 100- 125mg/dL or
- plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load
Exclusion Criteria:
- Actively losing weight
- Smokers
- Alcohol consumption > 2 drinks/day
- Prescription drug use
- Recreational drug use
- Type 2 Diabetes
- Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
pioglitizone
Arm Description
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
Outcomes
Primary Outcome Measures
Total and Active Ghrelin Levels
The primary outcome of this study will be the comparison of ghrelin suppressibility (total and acylated) in response to meals obese subjects before and after 3-months therapy with a thiazolidinedione.
Secondary Outcome Measures
Full Information
NCT ID
NCT00843791
First Posted
February 12, 2009
Last Updated
January 5, 2023
Sponsor
Oregon Health and Science University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00843791
Brief Title
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Official Title
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funds to continue.
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.
Detailed Description
Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
Arm Title
pioglitizone
Arm Type
Active Comparator
Arm Description
Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
treatment with placebo for 3 months
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
thiazolidinedione therapy
Intervention Description
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
Primary Outcome Measure Information:
Title
Total and Active Ghrelin Levels
Description
The primary outcome of this study will be the comparison of ghrelin suppressibility (total and acylated) in response to meals obese subjects before and after 3-months therapy with a thiazolidinedione.
Time Frame
0 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80, weight stable for at least 3 months
At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:
fasting plasma glucose level of 100- 125mg/dL or
plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load
Exclusion Criteria:
Actively losing weight
Smokers
Alcohol consumption > 2 drinks/day
Prescription drug use
Recreational drug use
Type 2 Diabetes
Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Q. Purnell, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
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