UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yumi Sato
Organization	Kawasaki Medical School
Division name	Department of Health Care Medicine
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	Yumi Sato
Organization	Kawasaki Hospital, Kawasaki Medical School
Division name	Health Care Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010808