Japan Diabetes Outcome Intervention Trial 1(J-DOIT1) : Intervention study to prevent or delay type 2 diabetes mellitus

UMIN ID: UMIN000000662

Registered date:30/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Impaired Fasting Glucose
• Date of first enrollment: 2007/03/01
• Target sample size: 3500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

"Diabetes Prevention Support", which is a health care support about diet and exercise mainly via phone call, provided by support service center.
Usual health care support using newsletter.

Outcome(s)

• Primary Outcome: Cumulative incidence of diabetes mellitus.
• Secondary Outcome: Changes of body weight, BMI, waist circumference, blood glucose, HbA1c, blood pressure, lipids, the prevalence of metabolic syndrome, and health behavior.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) persons with a previous diagnosis of diabetes mellitus other than gestational diabetes mellitus 2) persons who take diabetic medicine 3) persons whose HbA1c is 6.1% or higher 4) persons who are forbidden to do exercise by doctor 5) persons with pregnancy or possible pregnancy 6) persons who already receive diet and/or exercise recipe other than this study 7) persons with possible type 1 diabetes mellitus 8) persons with a diagnosis of liver cirrhosis or chronic viral hepatitis (type B or type C) 9) persons with cardiac pacemaker 10) persons who are forbidden to participate in this trial by doctor

Related Information

• Primary Sponsor: Japan Foundation for the Promotion of International Medical Research Cooperation
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare