UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009206 |
|---|---|
| Receipt number | 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 09:30:30 |
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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
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
yumi-sato@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Hospital, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010808
