UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Diabetes Outcome Intervention Trial 1(J-DOIT1) : Intervention study to prevent or delay type 2 diabetes mellitus
Title of the study (Brief title)	Japan Diabetes Outcome Intervention Trial 1(J-DOIT1)
Region	Japan

Condition
Condition	Impaired Fasting Glucose
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of "Diabetes Prevention Support" to prevent or delay diabetes mellitus in a high-risk group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cumulative incidence of diabetes mellitus.
Key secondary outcomes	Changes of body weight, BMI, waist circumference, blood glucose, HbA1c, blood pressure, lipids, the prevalence of metabolic syndrome, and health behavior.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	"Diabetes Prevention Support", which is a health care support about diet and exercise mainly via phone call, provided by support service center.
Interventions/Control_2	Usual health care support using newsletter.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) fasting blood glucose >/=100mg/dl and <126mg/dl 2) casual blood glucose >/=118mg/dl and <144mg/dl
Key exclusion 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
Target sample size	3500

Research contact person
Name of lead principal investigator	Hideshi Kuzuya
Organization	National Hospital Organization Kyoto Medical Center
Division name	The director of a hospital
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL	075-641-9161
Email	j-doit1@kyotolan.hosp.go.jp

Public contact
Name of contact person	Naoki Sakane
Organization	National Hospital Organization Kyoto Medical Center
Division name	Clinical Research Institute
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL	075-641-9161
Homepage URL
Email	j-doit1@kyotolan.hosp.go.jp

Sponsor
Institute	Japan Foundation for the Promotion of International Medical Research Cooperation
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2007 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 12 Month 11 Day
Anticipated trial start date	2007 Year 03 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 03 Month 30 Day
Last modified on	2017 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000798