Pioglitazone Decreases Visceral Fat Metabolism

Study Overview
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Brief Summary
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Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.

Official Title
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Effects of Pioglitazone on Visceral Fat Metabolic Activity

Conditions
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To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging

Intervention / Treatment
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* Drug: Pioglitazone vs Glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between the ages of 35 and 85 years Subjects with impaired glucose tolerance and type 2 diabetes Exclusion Criteria: Subjects with insulin treatment Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease Subjects taking more than three antidiabetic medications Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization Subjects with cardiac failure (New York Heart Association Class > III) or left ventricular dysfunction (LVEF < 40%) Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 58 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: 1<br>up to 30 mg pioglitazone, tablet, orally, once daily | Drug: Pioglitazone vs Glimepiride<br> <br> |
| Sham Comparator: Sham Comparator: 1<br>up to 4 mg/day glimepiride, tablet, orally, once daily | Drug: Pioglitazone vs Glimepiride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging. |  | Baseline and 16 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers |  | Baseline and 16 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin