Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study)

UMIN ID: C000000370

Registered date:27/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetic nephropathy with hyperlipidemia
• Date of first enrollment: 2004/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treated with simvastatin at 10 to 20mg/day per os for 1 year. An achieved LDL cholesterol level is 100mg/dL.
Treated with dietary intervention and antihyperlipidemic agents except HMG-CoA reductase inhibitors. An achieved LDL cholesterol level is 120mg/dL.

Outcome(s)

• Primary Outcome: urine albumin/creatinine ratio and its reduction rate. urine protein/creatinine ratio and its reduction rate.
• Secondary Outcome: creatinine clearance (Ccr). reciprocal of serum creatinine (1/Scr). HOMA-IR. urine protein, albumin and type IV collagen. serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, cystatin C, glucose and insulin.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Type 1 diabetes mellitus. 2) The subject has cardio-vascular complications as follows: receiving coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within 3 months; unstable angina; myocardial infarction; transient ischemic attack (TIA) within 6 months, congestive heart failure classified into class III or IV of New York Heart Association (NYHA); cerebral infarction within 3months. 3) The subject has non diabetic nephropathy such as chronic glomerulonephritis, nephrotic syndrome and polycystic kidney. 4) The subject's serum creatinine is more than 2.5mg/dL. 5) The subject has secondary hypertension except that due to diabetes. 6) The subject's HbA1c is more than 9%. 7) The subject is inappropriate for participation in the study for other reasons, as determined by an investigator.

Related Information

• Primary Sponsor: Japanese Society of Kidney and Lipids
• Source(s) of Monetary Support: Japan Kidney Foundation