UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Current Managements for Atherosclerotic Risk Factors in School Children
Title of the study (Brief title)	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	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City
TEL	096-373-5175
Email	sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	sueta-d@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040674