NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000662

Registered date:30/03/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedImpaired Fasting Glucose
Date of first enrollment2007/03/01
Target sample size3500
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeCumulative incidence of diabetes mellitus.
Secondary OutcomeChanges 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 minimum20years-old
Age maximum65years-old
GenderMale and Female
Include criteria1) fasting blood glucose >/=100mg/dl and <126mg/dl 2) casual blood glucose >/=118mg/dl and <144mg/dl
Exclude criteria1) 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

Contact

public contact
Name Naoki Sakane
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN Japan
Telephone 075-641-9161
E-mail j-doit1@kyotolan.hosp.go.jp
Affiliation National Hospital Organization Kyoto Medical Center Clinical Research Institute
scientific contact
Name Hideshi Kuzuya
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN Japan
Telephone 075-641-9161
E-mail j-doit1@kyotolan.hosp.go.jp
Affiliation National Hospital Organization Kyoto Medical Center The director of a hospital