UMIN-CTR Clinical Trial

Basic information
Public title	The examination of predictive factors and prognosis in nonalcoholic steatohepatitis
Acronym	The examination of predictive factors and prognosis in NASH
Scientific Title	The examination of predictive factors and prognosis in nonalcoholic steatohepatitis
Scientific Title:Acronym	The examination of predictive factors and prognosis in NASH
Region	Japan

Condition
Condition	Nonalcoholic steatohepatitis (NASH) Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to identify the associated factor of NASH using computed tomography, abdominal ultrasonography, blood test, and liver tissue. Additionally, we explore the prognosis of NAFLD. Finally, we investigated the risk factor for progression of NAFLD, metabolic diseases, and atherosclerotic diseases.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigate the associated factors for NASH Explore the predictive factors with prognosis of NAFLD
Key secondary outcomes	Identify the associated factors with histological fibrosis in the liver Identify the associated factors with histological fat droplets in the liver Identify the associated factors with histological inflammation in the liver Identify the associated factors with the severity of fibrosis and steatosis in the liver assessed by the ultrasonography Explore the predictive factors for progression of fibrosis in the liver Explore the predictive factors for onset of complication of liver Explore the predictive factors for onset of metabolic diseases Explore the predictive factors for onset of atherosclerotic diseases

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Male and female over twenty years of age Biopsy-proven NAFLD patients
Key exclusion criteria	Patients with pregnancy and lactation Patients with poor condition Persons judged inappropriate for this study
Target sample size	400

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
TEL	+81899605308
Homepage URL
Email	teruki-ygc@umin.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Self funding
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	The Ethics Committee of Ehime University Hospital
Address	Toon Ehime
Tel	+81899605914
Email	teruki-ygc@umin.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	2017 Year 12 Month 01 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	2017 Year 07 Month 27 Day
Date of IRB	2017 Year 09 Month 25 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aim of this study is to identify the associated factor of NASH using computed tomography, abdominal ultrasonography, blood test, and liver tissue. Additionally, we explore the prognosis of NAFLD. Finally, we investigated the risk factor for progression of NAFLD, metabolic diseases, and atherosclerotic diseases.

Management information
Registered date	2017 Year 12 Month 01 Day
Last modified on	2021 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034523