UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034565
Receipt number 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 2020/04/20 09:16:08

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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 Kiminori
Middle name
Last name 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

951-8510

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 Kiminori
Middle name
Last name 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

951-8510

Address

1-757 Asahimachi, Niigata Niigata 951-8510 Japan

TEL

025-368-9026

Homepage URL


Email

kkato48@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



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

Niigata University

Address

1-757 Asahimachi, Niigata 951-8510, Japan

Tel

025-368-9026

Email

kkato48@med.niigata-u.ac.jp


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

2020 Year 03 Month 31 Day

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

2020 Year 04 Month 20 Day



Link to view the page

Value
https://center6.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