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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016379
Receipt No. R000019026
Scientific Title Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases
Date of disclosure of the study information 2015/01/29
Last modified on 2020/02/03

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Basic information
Public title Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases
Acronym Examination of actual condition and predictive factor for NAFLD
Scientific Title Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases
Scientific Title:Acronym Examination of actual condition and predictive factor for NAFLD
Region
Japan

Condition
Condition Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)
Metabolic 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 prevalence of NAFLD and NASH among the outpatients with metabolic diseases. Next, we explore the associated factor between pathophysiology of NAFLD and NASH, and lifestyle and biochemical test and physical examination. Finally, we investigated the predictive factor for onset of NAFLD, NASH, metabolic diseases, cancer, arteriosclerotic disease in prospective study.
Basic objectives2 Others
Basic objectives -Others exploration
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1.Identify prevalence of NAFLD among the patients with metabolic disease.
2.Explore the associated factor between pathophysiology of NAFLD, and lifestyle and biochemical test and physical examination.
3.Investigate the predictive factor for onset and exacerbating factor of NAFLD among the patients with metabolic disease.
4.Investigate the predictive factor for onset and exacerbating factor of metabolic diseases among the patients with metabolic disease among the patients with metabolic disease.
5.Investigate prevalence and associated factor of cancer onset among the patients with metabolic disease.
6.Investigate prevalence and associated factor of arteriosclerotic disease among the patients with metabolic disease.
Key secondary outcomes 1.Compare the diagnosability of NAFLD/NASH between associated factor of NAFLD in this study and score system of NAFLD/NASH
2.Evaluate the correlation between associated factor of NAFLD in this study and serum marker of NAFLD/NASH

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. Male and female over twenty years of age
2. Patients agree with participation
Key exclusion criteria 1. Patients with pregnancy and lactation
2. Patients with poor condition
3. Persons judged inappropriate for this study
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Teruki
Middle name
Last name Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Toon City, Ehime, Japan
TEL +81899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name Teruki
Middle name
Last name Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Toon City, Ehime, Japan
TEL +81899605308
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 Other
Nationality of Funding Organization JAPAN (JPN)

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Ehime University Hospital
Address Shitsukawa Toon
Tel 089-960-5914
Email rinri@m.ehime-u.ac.jp

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
2015 Year 01 Month 29 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
2013 Year 11 Month 01 Day
Date of IRB
2013 Year 10 Month 28 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2023 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2015 Year 01 Month 29 Day
Last modified on
2020 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019026

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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