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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013239
Receipt No. 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

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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
Email 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
Email a-morita@koshien.ac.jp

Sponsor
Institute Incorporated Administrative Agency National Institute of Health and Nutrition
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013685

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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