Anti-Inflammatory Effects of Pioglitazone

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kurume University
• Treatments: Anti-Inflammatory Agents; Glimepiride; Pioglitazone

Criteria

Inclusion Criteria:

• Subjects between the ages of 35 and 85 years

• Subjects with impaired glucose tolerance and type 2 diabetes, who had atherosclerosis detected by carotid ultrasound and/or CT

• Subjects who had vascular FDG uptake by FDG-PET

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 (TZDs) 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