UMIN-CTR Clinical Trial

Basic information
Public title	The effect of metabolic syndrome and associated genetic factors on fatty liver disease
Acronym	metabolic syndrome-related genetic factors on fatty liver
Scientific Title	The effect of metabolic syndrome and associated genetic factors on fatty liver disease
Scientific Title:Acronym	metabolic syndrome-related genetic factors on fatty liver
Region	Japan

Condition
Condition	Non alcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	the aim of this study is to estimate the frequencies and impact of genetic factors such as PNPLA3, NCAN, LYPLL1, GCKR, PPP1R3b, CYP17A1, NT5C2, ADIPOQ, TM6SF2 and TLL1 to the pathology of patients with fatty liver disease.
Basic objectives2	Others
Basic objectives -Others	the effect of SNPs to hepatic histological change.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the frequencies of SNPs and the effect on hepatic histological findings
Key secondary outcomes	the effect on prognosis. the effect on malignancies.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the patients receiving medical checkups in our department.
Key exclusion criteria	patients with hepatitis B surface antigen-positive and hepatitis C virus antibody-positive, 2) ongoing treatment for thyroid disease, hormone therapy,
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name kanji Yamaguchi Middle name Last name Kanji Yamaguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	6028566
Address	Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL	+81-75-251-5519
Email	yuyaseko@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name yuya seko Middle name Last name Yuya Seko
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	6028566
Address	Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL	+81-75-251-5519
Homepage URL
Email	yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kamigyo-ku
Tel	0752515519
Email	rinri@koto.kpu-m.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	2018 Year 04 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	2016 Year 11 Month 29 Day
Date of IRB	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 07 Month 11 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	the association between the variants of SNPs and histological changing.

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2021 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031398