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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006230
Receipt No. R000007366
Scientific Title A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Date of disclosure of the study information 2011/08/25
Last modified on 2017/03/01

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Basic information
Public title A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Acronym Risk Factors of NAFLD
Scientific Title A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Takamasa Ohki
Organization Mitsui Memorial Hospital
Department of Gastroenterology
Division name Department of Gastroenterology
Zip code
Address Kanda-izumicho Ichi-banchi Chiyoda ward Tokyo Japan
TEL 03-3862-9111
Email anb72547@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Ohki
Organization Mitsui Memorial Hospital
Division name Department of Gastroenterology
Zip code
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)

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 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

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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 24 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007366

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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