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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000370

Enrollment

200

Registered

2006-03-27

Start date

2004-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic nephropathy with hyperlipidemia

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The subject has not needed to be treated with insulin during 6 months after the diagnosis of type 2 diabetes mellitus. 2) The subject is hyperlipidemic with more than 200mg/dL of serum total cholesterol or more than 120mg/dL of serum LDL cholesterol. 3) The subject's urine protein/creatinine ratio is between 300 and 3500mg/gCr. 4) The subject's blood pressure has been controlled in less than 140/90mmHg for more than 3months. 5) The subject has voluntarily signed a document of the informed consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
urine albumin/creatinine ratio and its reduction rate. urine protein/creatinine ratio and its reduction rate.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactTakao Saito

Japanese Society of Kidney and Lipids Division of Nephrology and Rheumatology, Fukuoka University Hospital

tsaito@fukuoka-u.ac.jp092-801-1011ext.3374

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026