UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the effect of alcohol on fatty liver disease.
Title of the study (Brief title)	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	YUYA SEKO
Organization	Kyoto Prefectural University of Medeicine
Division name	Department of Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	0752515519
Email	yuyaseko@koto.kpu-m.ac.jp

Public contact
Name of contact person	YUYA SEKO
Organization	Kyoto Prefectural University of Medeicine
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032885