UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013239 |
|---|---|
| Receipt number | R000013685 |
| Scientific Title | A cohort study for the prevention of lifestyle-related diseases [Saku Cohort Study for Healthy Aging] |
| Date of disclosure of the study information | 2014/02/24 |
| Last modified on | 2014/02/25 16:41:06 |
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Basic information
Public title
A cohort study for the prevention of lifestyle-related diseases [Saku Cohort Study for Healthy Aging]
Acronym
Saku Cohort Study for Healthy Aging
Scientific Title
A cohort study for the prevention of lifestyle-related diseases [Saku Cohort Study for Healthy Aging]
Scientific Title:Acronym
Saku Cohort Study for Healthy Aging
Region
| Japan |
Condition
Condition
lifestyle-related disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the risk of developing diabetes and cardiovascular disease in people with the metabolic syndrome
Basic objectives2
Others
Basic objectives -Others
To evaluate the predictive factors for the development of the metabolic syndrome and lifestyle-related diseases including diabetes and cardiovascular disease in a cohort study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of the risk factors of developing of the lifestyle-related diseases
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Health checkup examinees
Key exclusion criteria
Not applicable
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suminori Kono / Shaw Watanabe |
Organization
Incorporated Administrative Agency National Institute of Health and Nutrition
Division name
President / Former President
Zip code
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8636, JAPAN
TEL
03-3203-5730
kono-s@nih.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akemi Morita |
Organization
Koshien University
Division name
Department of Nutrition
Zip code
Address
10-1 Momijigaoka, Takarazuka, Hyogo, 665-0006, JAPAN
TEL
0797-87-8078
Homepage URL
a-morita@koshien.ac.jp
Sponsor or person
Institute
Incorporated Administrative Agency National Institute of Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
佐久総合病院
Saku Central Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up of the participants by collecting their health checkup data prospectively.
Management information
Registered date
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2014 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013685
