Anti-Inflammatory Effects of Pioglitazone

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722631
• Other study ID #: PIO 2007
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: September 26, 2012
• Start date: May 2007
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Kurume University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone
Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
• Glimepiride
Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.

Locations

Country	Name	City	State
Japan	Kurume University Hospital	Kurume city

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change from baseline in plasma glucose/insulin homeostatic parameters and circulating markers of atherosclerosis		Baseline and 4 months and 5 years after treatment	Yes
Secondary	Change from baseline in visceral fat		Baseline and 4 months and 5 years after treatment	Yes
Secondary	All cardiovascular events and all cause death for 5 years		Baseline and 4 months and 5 years after treatment	Yes