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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034565
Receipt No. R000039408
Scientific Title Construction of the "Niigata Model" as the Third Phase Specific Health Guidance (Pilot Study)
Date of disclosure of the study information 2018/10/19
Last modified on 2018/10/19

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Basic information
Public title Construction of the "Niigata Model" as the Third Phase Specific Health Guidance (Pilot Study)
Acronym Construction of the "Niigata Model" as the Third Phase Specific Health Guidance (Pilot Study)
Scientific Title Construction of the "Niigata Model" as the Third Phase Specific Health Guidance (Pilot Study)
Scientific Title:Acronym Construction of the "Niigata Model" as the Third Phase Specific Health Guidance (Pilot Study)
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 tarnslation-in-progress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes tarnslation-in-progress
Key secondary outcomes tarnslation-in-progress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 tarnslation-in-progress
Interventions/Control_2 0 point
Interventions/Control_3 20 point
Interventions/Control_4 100 point
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria tarnslation-in-progress
Key exclusion criteria tarnslation-in-progress
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiminori Kato
Organization Graduate School of Medical and Dental Sciences
Niigata University
Division name Department of Laboratory Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseases
Zip code
Address 1-757 Asahimachi, Niigata Niigata 951-8510 Japan
TEL 025-368-9026
Email kkato48@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiminori Kato
Organization Graduate School of Medical and Dental Sciences Niigata University
Division name Department of Laboratory Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseas
Zip code
Address 1-757 Asahimachi, Niigata Niigata 951-8510 Japan
TEL 025-368-9026
Homepage URL
Email kkato48@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2018 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039408

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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