UMIN-CTR Clinical Trial

Basic information
Public title	Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Acronym	Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Scientific Title	Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Scientific Title:Acronym	Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Region	Japan

Condition
Condition	Nonalcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We assess the consumption of cholesterol in relation to disease progression with Japanese NAFLD patients.
Basic objectives2	Others
Basic objectives -Others	The relation between the consumption of cholesterol and the liver fibrosis, steatosis, inflammation, and hepatocellular ballooning
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To assess the relation between the consumption of cholesterol and the liver fibrosis, steatosis, inflammation, and hepatocellular ballooning which were diagnosed with liver biopsy
Key secondary outcomes	To assess the relation between the consumption of cholesterol and AST, ALT, GTP, liver stiffness measurement, bile acid composition, and sterol oxidations

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) NAFLD patients who were diagnosed with liver biopsy within 1 year before a written informed consent. (2) Alcohol consumption (ethanol equivalent volume), <30 g/day for men, <20 g/day for women.
Key exclusion criteria	(1) History of chronic hepatic disease (viral hepatic disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis (2) Hepatocellular carcinoma and other malignant diseases (3) Patients judged inappropriate by doctor or investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Kamada
Organization	Osaka University Graduate School of Medicine
Division name	Department of Molecular Biochemistry & Clinical Investigation
Zip code	565-0871
Address	2-2 K1, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Email	ykamada@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Michihiro Middle name Last name Iwaki
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL	045-787-2640
Homepage URL
Email	michihir@yokohama-cu.ac.jp

Sponsor
Institute	Department of Molecular Biochemistry & Clinical Investigation, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University Department of Gastroenterology, JA Hiroshima General Hospital Department of Gastroenterology and Metabolism, Institute of Biomedical & Health Sciences, Hiroshima University Division of Cardiovascular Medicine, Department of Medicine, Osaka University Graduate School of Medicine Maeda Clinic Department of Health and Nutrition Sciences,Faculty of Human Life Sciences, Nagoya Keizai University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saga University Hospital
Address	5-1-1, Nabeshima, Saga
Tel	0952-34-3010
Email	takahas2@cc.saga-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2020-03-02
Org. issuing International ID_1	Saga University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 23 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	2020 Year 04 Month 10 Day
Date of IRB	2020 Year 06 Month 01 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is observational study.

Management information
Registered date	2020 Year 06 Month 23 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046635