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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009206
Receipt No. R000010808
Scientific Title Correlativity of each physical measurement index (the abdominal circumference, BMI, abdominal circumference height ratio) and CT measurement visceral fat area in consideration of sex difference
Date of disclosure of the study information 2013/02/01
Last modified on 2017/11/01

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Basic information
Public title Correlativity of each physical measurement index (the abdominal circumference, BMI, abdominal circumference height ratio) and CT measurement visceral fat area in consideration of sex difference
Acronym Each physical measurement index and visceral fat study
Scientific Title Correlativity of each physical measurement index (the abdominal circumference, BMI, abdominal circumference height ratio) and CT measurement visceral fat area in consideration of sex difference
Scientific Title:Acronym Each physical measurement index and visceral fat study
Region
Japan

Condition
Condition Of 100 staff at Kawasaki Hospital of Kawasaki Medical School
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research examines the most useful physical measurement index as an overweight judging or lifestyle-related disease evaluation at the time of a personnel medical checkup.
Furthermore, the validity of the index of the present lifestyle-related disease is verified by considering a temporal change and examining the relevance of a blood test result and visceral fat area about the development-of-symptoms risk of a lifestyle-related disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of visceral fat and the relation of each factor
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 visceral fat accumulation
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
35 years-old <
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Subjects had underwent annual health check-up, and the study was approved by the human ethics committee of Osaka University and a written informed consent was obtained from each participant
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumi Sato
Organization Kawasaki Medical School
Division name Department of Health Care Medicine
Zip code
Address 577 Matsushima, Kurashiki 701-0192 , JAPAN
TEL 086-225-2111
Email yumi-sato@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Sato
Organization Kawasaki Hospital, Kawasaki Medical School
Division name Health Care Center
Zip code
Address 2-1-80, Nakasange, Kita-ku, Okayama-shi Okayama 700-8505, Japan
TEL 086-225-2111
Homepage URL
Email yumi-sato@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Hospital, Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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 川崎医科大学附属川崎病院(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2012 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 28 Day
Last modified on
2017 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010808

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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