UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000019026