Anti-Inflammatory Effects of Pioglitazone

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Atherosclerosis
• Interventions: Drug: Pioglitazone; Drug: Glimepiride

• Registration Number: NCT00722631
• Lead Sponsor: Kurume University

Brief 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.

Detailed Description

Atherosclerotic patients with impaired glucose tolerance and type 2 diabetes will undergo the FDG-PET/CT imaging at baseline and again following 4 months after treatment. Patients who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone or 4 mg/day glimepiride. Physical examinations will be done at baseline, 4 months, and 12 months. During study, subjects will have body weight, and vital signs (HR, BP, etc) assessed as well as waist circumference. Laboratory assessments will be done at each baseline, 4 month.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Primary Completion: 2009-04
• Study Completion: 2012-04
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pioglitazone	up to 30 mg pioglitazone, tablet, orally, once daily
2	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 atherosclerotic plaque from baseline after 4 months of treatment as measured by FDG-PET/CT imaging.	Baseline and 4 months after treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis	Baseline and 4 months and 5 years after treatment
Change from baseline in visceral fat	Baseline and 4 months and 5 years after treatment
All cardiovascular events and all cause death for 5 years	Baseline and 4 months and 5 years after treatment

Trial Locations

Locations (1)

Kurume University Hospital; 🇯🇵 Kurume city, Japan