NCT00722631

Anti-Inflammatory Effects of Pioglitazone

Detection of Plaque Inflammation and Visualization of Anti-Inflammatory Effects of Pioglitazone on Plaque Inflammation in Subjects With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus by FDG-PET/CT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kurume University · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Pioglitazone	Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
DRUG	Glimepiride	Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-04-01
• Completion: 2012-04-01
• First posted: 2008-07-25
• Last updated: 2012-09-27

Locations

1 site across 1 country: Japan