Japan Elderly Diabetes Intervention Study

UMIN ID: UMIN000000890

Registered date:22/11/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Diabetes Mellitus in the Elderly
• Date of first enrollment: 2001/03/01
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intensive treatment group: HbA1c<6.5%, Blood preesure <130/85mmHg,Total cholesterol:<180mg/dl (If CHD is present), or <200mg/dl (If CHD is absent),Triglycerides<150mg/dl, HDL cholesterol>40mg/dl, and BMI<25.
Conventional treatment group: goals as attending doctors consider to be proper. :at least fasting plasma glucose <200mg/dl or HbA1c<9.0%

Outcome(s)

• Primary Outcome: 1.Fatal endpoints: diabetes-specific death including cardiovaslular death, and non-diabetes-specific death 2.Non-fatal endpoints: acute myocardial infarction, other IHDs, cerebrovascular disease, arterial peripheral vascular disease, diabetic gangrene, and the blindness due to diabetic retinopathy.
• Secondary Outcome: Diabetic microangiopathy(reitinopathy, nephropathy,neuropathy), vitreous hemorrhage, congestive heart failure, and retinal photocoagulation.

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: type 1 diabetes acute disease malignancy

Related Information

• Primary Sponsor: Japan Foundation for Health and Aging
• Source(s) of Monetary Support: Japan Foundation for Health and Aging