UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035707
Receipt number R000040674
Scientific Title Current Managements for Atherosclerotic Risk Factors in School Children
Date of disclosure of the study information 2019/01/29
Last modified on 2019/01/29 09:01:56

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Basic information

Public title

Current Managements for Atherosclerotic Risk Factors in School Children

Acronym

health crisis in childhood

Scientific Title

Current Managements for Atherosclerotic Risk Factors in School Children

Scientific Title:Acronym

health crisis in childhood

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Ischemic heart disease is a major cause of mortality in Europe and the United States, but in recent years, along with Westernization of lifestyle westernization, increase in morbidity rate and mortality rate is a problem. From the viewpoint that arteriosclerotic diseases such as ischemic heart disease develop and develop according to lifestyle habits, in recent years, the necessity of intensive and fundamental correspondence from childhood as a preventive strategy is discussed There. That is, arteriosclerotic lesions, which are the disease basis of coronary artery disease, have already been progressed pathologically by the existence of risk factors for their early lesions in childhood. In addition, it is also evidence that reduction in risk can delay the onset of arteriosclerosis and change its course also has been proven with many evidences, the era in which primary prevention of coronary artery disease should begin in childhood It can be said that it has arrived. Diagnostic criteria for metabolic syndrome have already been established in childhood, and necessary interventions such as exercise and diet are being carried out at school and home based on that, but the effect is not clear. By clarifying the management status of various lifestyle - related disease parameters in childhood this time, it becomes possible to review the future intervention strategy. We believe that publishing the results of this research will be an enlightenment for society, and think that its social significance is great.

Basic objectives2

Others

Basic objectives -Others

Observational studies will clarify the lipid metabolic profile at school age.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lipid metabolism profile in school age

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

11 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

All 12-year-old children in Nagomi-cho, Kumamoto Prefecture

Key exclusion criteria

none

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Sueta

Organization

Kumamoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1 Honjo, Kumamoto City

TEL

096-373-5175

Email

sueta-d@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Sueta

Organization

Kumamoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1 Honjo, Kumamoto City

TEL

096-373-5175

Homepage URL


Email

sueta-d@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kumamoto University Hospital

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

2019 Year 01 Month 29 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

Open public recruiting

Date of protocol fixation

2019 Year 01 Month 29 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 29 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study was a community-based, prospective, registry study


Management information

Registered date

2019 Year 01 Month 29 Day

Last modified on

2019 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name