Japan Diabetes Complications Study

UMIN ID: C000000222

Registered date:01/12/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: diabetes mellitus
• Date of first enrollment: 1996/01/01
• Target sample size: 2000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The patients in the control group received regular conventional care of diabetologists without any changes before or during the study period.
1) For patients in the intervention group, dietary habits, physical activities and adherence to the treatments were managed intensively during outpatient clinic visits in addition to routine conventional treatment. 2) Treatment goals were set for patients in the intervention group regarding weight, glycemic, blood pressure, and serum lipid control, smoking, alcohol drinking, etc. 3) Patients in the intervention group also received telephone counseling sessions by trained educators. Patients in the intervention group received educational materials discussing various aspects of diabetes care.

Outcome(s)

• Primary Outcome: Parameters and indices related to glycemic control, diabetic complications, dyslipidemia, hypertension, obesity and atherosclerosis were measured several times a year.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Patients with serum creatinine levels greater than 1.3 mg/dl, nephrotic syndrome, history of angina pectoris and/or myocardial infarction, ischemic cerebral vascular events, arteriosclerosis obliterans, familial hypercholesterolemia or type III hyperlipidemia were excluded as subjects for macroangiopathy analysis. With regard to microangiopathy analysis, patients with a history of intra-ocular surgeries or non-diabetic nephropathy were excluded. The patients studied had no baseline diabetic retinopathy (subjects for primary retinopathy prevention analysis) or minimal background retinopathy (subjects for secondary retinopathy prevention analysis).

Related Information

• Primary Sponsor: Japan Diabetes Complications Study(JDCS) group
• Source(s) of Monetary Support: The Health Sciences Research Grants (Research on Health Services),Ministry of Health Labor and Welfare, Japan