UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000662 |
|---|---|
| Receipt number | 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 15:29:04 |
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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
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
j-doit1@kyotolan.hosp.go.jp
Sponsor or person
Institute
Japan Foundation for the Promotion of International Medical Research Cooperation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000798
