Effects of pioglitazone on abdominal fat and reactive oxygen species in type 2 diabetes mellitus

UMIN ID: C000000441

Registered date:05/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2005/09/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pioglitazone+diet
diet only

Outcome(s)

• Primary Outcome: - Abdominal fat mass - ROS (reactive oxygen species) - Blood lipid parameters
• Secondary Outcome: - Glycemic control (OGTT, HbA1c) - Cardiac function - Aortic stiffness (Pulse wave velocity)

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 70years-old
• Gender: Male
• Exclude criteria: - History of cerebro- and cardio-vascular disease - History of congestive heart failure - History of ketoacidosis or diabetic coma - Moderate to severe liver dysfunction - Moderate to severe renal dysfunction - Moderate to severe infection, before and after operation, severe trauma - Contraindication to antidiabetic medication

Related Information

• Primary Sponsor: Second Department of Internal Medicine, Faculty of Medicine, University of the Ryukyus, Diabetes and Life-style related disease center, Tomishiro Chuo Hospital
• Source(s) of Monetary Support: Second Department of Internal Medicine, Faculty of Medicine, University of the Ryukyus, Diabetes and Life-style related disease center, Tomishiro Chuo Hospital