UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Title of the study (Brief title)	Risk Factors of NAFLD
Region	Japan

Condition
Condition	Healthy people who receive medical checkup
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease (NAFLD).
Basic objectives2	Others
Basic objectives -Others	To clarify the incidence of NAFLD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Development of NAFLD.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Age equal to 20 or over 20 years old. 2.No evidence of HCV, HBV, or syphilis infection. 3.Taking alcohol less than 20g/day. 4.Diagnosis of fatty liver.
Key exclusion criteria	1.Patients reject to participate into this study. 2.Follow up period less than a year. 3.Patients who were ruled unfit to this study for any other reasons.
Target sample size	1000

Research contact person
Name of lead principal investigator	Takamasa Ohki
Organization	Mitsui Memorial Hospital Department of Gastroenterology
Division name	Department of Gastroenterology
Address	Kanda-izumicho Ichi-banchi Chiyoda ward Tokyo Japan
TEL	03-3862-9111
Email	anb72547@nifty.com

Public contact
Name of contact person	Takamasa Ohki
Organization	Mitsui Memorial Hospital
Division name	Department of Gastroenterology
Address	Kanda-izumicho Ichi-banchi Chiyoda ward Tokyo Japan
TEL	03-3862-9111
Homepage URL
Email	anb72547@nifty.com

Sponsor
Institute	Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization	Mitsui Memorial Hospital
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	三井記念病院、三井記念病院健診センター

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 08 Month 24 Day
Anticipated trial start date	2011 Year 08 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	Open for registration.

Management information
Registered date	2011 Year 08 Month 25 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007366