Effects of pioglitazone on coronary atherosclerotic plaques of patients with impaired glucose tolerance or type 2 diabetes mellitus:a randomized,open rabelled,prospective study.

UMIN ID: C000000230

Registered date:01/12/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Impaired glucose tolerance or type 2 diabetes mellitus with coronary artery disease
• Date of first enrollment: 2003/03/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention group:Start to take pioglitazone 15mg per day after percutaneous coronary angioplasty and increase a dose to 30mg per day at 14days after angioplasty.And continue in 6 months.
Control group:Take no pioglitazone in 6 months after percutaneous coronary angioplasty.

Outcome(s)

• Primary Outcome: Plaque volume,vessel volume,lumen volume and radiofrquency data assessed with intravascular ultrasound. Plasma glucose,HbA1C,insulin,total cholesterol,triglyceride,LDL,HDL,MDA-LDL,8-isoprostane,MMP-9,MCP-1,PAI-1,TNF-a and hsCRP. Major adverse cardiovascular event and harmful effect of pioglitazone
• Secondary Outcome: Plasma GOT,GPT,T-BIL,CPK,ALP,G-GTP and LDH

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Heart failure,acute myocardial infarction,severe hepatic or renal dysfunction,to take insulin,already to take pioglitazone,episode of adverse effect by troglitazone,pregnancy and severe hypercholesterolemia.

Related Information

• Primary Sponsor: Chiba University Graduate School of Medicine
• Secondary Sponsor: Kimitsu Central Hospital
• Source(s) of Monetary Support: None