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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011953
Receipt No. R000013957
Scientific Title Predictive factor for nonalcoholic fatty liver disease among subjects undergoing health check up
Date of disclosure of the study information 2013/10/03
Last modified on 2017/03/26

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Basic information
Public title Predictive factor for nonalcoholic fatty liver disease among subjects undergoing health check up
Acronym Predictive factor for NAFLD
Scientific Title Predictive factor for nonalcoholic fatty liver disease among subjects undergoing health check up
Scientific Title:Acronym Predictive factor for NAFLD
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to identify previously undiagnosed cases of NAFLD by setting up a proper cutoff level of alanine aminotransferase (ALT) cutoff level, and to explore predictive factors for NAFLD and onset of NAFLD.
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Setting up a proper cutoff level of alanine aminotransferase (ALT) cutoff level to identify previously undiagnosed cases of NAFLD
2. Identify predictive factors for presence of NAFLD
3. Identify predictive factors for onset of NAFLD.
4. Identify predictive factors for metabolic diseases.
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. over 18 years
Key exclusion criteria (1) consumption of more than 20 g/day alcohol
(2) positive for HBs-Ag or anti-HCV
(3) evidence of liver disease other than viral hepatitis, such as autoimmune hepatitis or primary biliary cirrhosis
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime, Japan
TEL 0899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime, Japan
TEL 0899605308
Homepage URL
Email teruki-ygc@umin.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2013 Year 10 Month 03 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 04 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 05 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 In this community-based study, we review the medical records of Japanese subjects (age range, 18-90 years), who had undergone at least 1 annual health checkup between April 2003 and March 2014. The annual health checkup includes recording the subject's lifestyle habits, medical history, and history of prescribed medication; conducting a physical examination; and measuring anthropometric and routine biochemical variables. We explore predictive factors for NAFLD and metabolic disease.

Management information
Registered date
2013 Year 10 Month 03 Day
Last modified on
2017 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013957

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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