Effects of pioglitazone and metformin on mitochondrial function evaluated with 31P MRS in type 2 DM.

UMIN ID: UMIN000000814

Registered date:01/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2007/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pioglitazone (15-30mg/day)
metformin (750mg/day)

Outcome(s)

• Primary Outcome: Measurement of mitochondrial function of skeletal muscle before and after 24 weeks treatment with different insulin sensitizers.
• Secondary Outcome: 1. Measurement of the amount of visceral fat, IMCL and HLC before and after 24 weeks treatment. 2. Measurement of GIR before and after 24 weeks treatment. 3. Measurement of FPG, IRI, HbA1c, total-cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, FFA, adipocytokines before and after 24 weeks treatment. 4. Measurement of body weight and waist before and after 24 weeks treatment.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Severe renal dysfunction(serum creatinine>2.0mg/dl) 2. Severe liver dysfunction(AST, ALT>50IU/ml) 3. Severe heart failure 4. History of hypersensitivity to pioglitazone or metformin 5. During the pregnancy or nursing 6. Arteriosclerosis obliterans (ASO) (ABI<0.9) 7. Poor control of plasma glucose (FPG>150mg/dl) 8. Inadequate to entry to this study

Related Information

• Primary Sponsor: Kobe University Hospital
• Secondary Sponsor: Kobe University Graduate School of Medicine Department of radiology
• Source(s) of Monetary Support: None