To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging
Conditions
Keywords
visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers | Baseline and 16 weeks after treatment |
Other
| Measure | Time frame |
|---|---|
| All cardiovascular events and all cause death for 5 years | Baseline and 5 years after treatment |
Countries
Japan