Anti-Inflammatory Effects of Pioglitazone

Condition(s) targeted: Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Atherosclerosis

Intervention: Pioglitazone (Drug); Glimepiride (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Kurume University

Official(s) and/or principal investigator(s):
Nobuhiro Tahara, MD, PhD, Principal Investigator, Affiliation: Kurume University

Overall contact:
Nobuhiro Tahara, MD, PhD, Phone: +81-942-31-7580, Email: ntahara@med.kurume-u.ac.jp

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.

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis

Change from baseline in visceral fat

All cardiovascular events and all cause death for 5 years

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.

Minimum age: 35 Years. Maximum age: 85 Years. Gender(s): Both.

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

Nobuhiro Tahara, MD, PhD, Phone: +81-942-31-7580, Email: ntahara@med.kurume-u.ac.jp

Kurume University Hospital, Kurume city 830-0011, Japan; Recruiting
Nobuhiro Tahara, MD, PhD, Phone: +81-942-31-7580, Email: ntahara@med.kurume-u.ac.jp
Minori Mizoguchi, MD, Phone: +81-942-31-7562
Nobuhiro Tahara, MD, PhD, Principal Investigator

Starting date: May 2007
Ending date: May 2012
Last updated: September 16, 2009