Pioglitazone Decreases Visceral Fat Metabolism

Not Applicable

• Conditions: To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging
• Interventions: Drug: Pioglitazone vs Glimepiride

• Registration Number: NCT01819402
• Lead Sponsor: Kurume University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-03
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-24
• Last Update Submitted: 2013-03-24
• Study First Posted: 2013-03-27
• Last Update Posted: 2013-03-27
• Primary Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Comparator: 1	Pioglitazone vs Glimepiride	up to 30 mg pioglitazone, tablet, orally, once daily
Sham Comparator: 1	Pioglitazone vs Glimepiride	up to 4 mg/day glimepiride, tablet, orally, once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers	Baseline and 16 weeks after treatment

Trial Locations

Locations (1)

Kurume University; 🇯🇵 Kurume, Japan