Pioglitazone Decreases Visceral Fat Metabolism

Kurume University

Status: Unknown

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

Treatments: Drug: Pioglitazone vs Glimepiride

Study type: Interventional

Funder types: Other

Identifiers

NCT01819402

PIO FAT

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 58 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Active Comparator: 1

Active Comparator group

Description:

up to 30 mg pioglitazone, tablet, orally, once daily

Treatment:

Drug: Pioglitazone vs Glimepiride

Sham Comparator: 1

Sham Comparator group

Description:

up to 4 mg/day glimepiride, tablet, orally, once daily

Treatment:

Drug: Pioglitazone vs Glimepiride