UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013042 |
|---|---|
| Receipt number | R000014718 |
| Scientific Title | Usability of Health guidance with Measurement of Visceral Fat Area by bioelectrical impedance Method |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2015/10/28 15:25:31 |
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Basic information
Public title
Usability of Health guidance with Measurement of Visceral Fat Area by bioelectrical impedance Method
Acronym
Usability of Health guidance with Measurement of Visceral Fat Area by bioelectrical impedance Method
Scientific Title
Usability of Health guidance with Measurement of Visceral Fat Area by bioelectrical impedance Method
Scientific Title:Acronym
Usability of Health guidance with Measurement of Visceral Fat Area by bioelectrical impedance Method
Region
| Japan |
Condition
Condition
Nonalcholic Fatty Liver Disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usability of health guidance with estimated Viseceral Fat Area measurement by BIA for the employees with less than 20g per day of alcohol intake whose liver function abnormalities were pointed out in a medical examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated Viseceral Fat Area measurement by BIA
Key secondary outcomes
Medical examination data of 2013,2014
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
| Device,equipment | Behavior,custom |
Interventions/Control_1
-Estimated VFA measurement with health guidance every 2weeks or 4weeks
-Dietary and exercise instructions while monitoring
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-ALT>=40
-Persons pointed out fatty liver in Ultra Sonography
-Persons whose waist perimeter were not less than 85 cm
-Persons under 20g per day of alcohol intake
Key exclusion criteria
-Persons under treatment with diabets
-Persons under treatment with hepatitis B,C
-Persons under treatment autoimmune hepatitis
-Persons within 5kg body weight in a year
-Persons judged inapproriate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Maeda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka .Suita,Osaka
TEL
06-6879-3498
kaz@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Yoshida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka .Suita,Osaka
TEL
06-6879-3498
Homepage URL
m-yoshida@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Complementary and Alternative Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yodogawa Christian Hospital
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014718
