Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Drug: placebo
* Drug: pioglitazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. | Drug: placebo<br>* treatment with placebo for 3 months<br>|
| Active Comparator: pioglitizone<br>Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy. | Drug: pioglitazone<br>* treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months<br>* Other names: thiazolidinedione therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity