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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028735
Receipt No. R000032885
Scientific Title the effect of alcohol on fatty liver disease.
Date of disclosure of the study information 2017/09/30
Last modified on 2018/08/20

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Basic information
Public title the effect of alcohol on fatty liver disease.
Acronym the effect of alcohol on fatty liver disease.
Scientific Title the effect of alcohol on fatty liver disease.
Scientific Title:Acronym the effect of alcohol on fatty liver disease.
Region
Japan

Condition
Condition fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to analyze the relationship between alcoholic intake and fatty liver disease.
Basic objectives2 Others
Basic objectives -Others the factors associated with development fatty liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the cut off value of alcoholic intake of development fatty liver disease.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Japanese individuals who participated in
health checkups, or patients who underwent liver biopsy.
Key exclusion criteria (1) patients positive for hepatitis B
surface antigen and hepatitis C virus antibody, (2) patients
under treatment for thyroid disease or hormone therapy
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YUYA SEKO
Organization Kyoto Prefectural University of Medeicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto
TEL 0752515519
Email yuyaseko@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YUYA SEKO
Organization Kyoto Prefectural University of Medeicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto
TEL 0752515519
Homepage URL
Email yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medeicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medeicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2017 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 the aim of this study is to analyze the association between alcoholic intake and fatty liver disease.

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032885

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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