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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000662
Receipt No. R000000798
Scientific Title Japan Diabetes Outcome Intervention Trial 1(J-DOIT1) : Intervention study to prevent or delay type 2 diabetes mellitus
Date of disclosure of the study information 2007/03/30
Last modified on 2017/03/10

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Basic information
Public title Japan Diabetes Outcome Intervention Trial 1(J-DOIT1) : Intervention study to prevent or delay type 2 diabetes mellitus
Acronym Japan Diabetes Outcome Intervention Trial 1(J-DOIT1)
Scientific Title Japan Diabetes Outcome Intervention Trial 1(J-DOIT1) : Intervention study to prevent or delay type 2 diabetes mellitus
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideshi Kuzuya
Organization National Hospital Organization Kyoto Medical Center
Division name The director of a hospital
Zip code
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
1st name
Middle name
Last name Naoki Sakane
Organization National Hospital Organization Kyoto Medical Center
Division name Clinical Research Institute
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 12 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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