UMIN-CTR Clinical Trial

Basic information
Public title	Progressing factors of nonalcoholic fatty liver disease(NAFLD)by gene analysis of serial liver biopsies.
Acronym	Progressing factors of nonalcoholic fatty liver disease(NAFLD)by gene analysis of serial liver biopsies.
Scientific Title	Progressing factors of nonalcoholic fatty liver disease(NAFLD)by gene analysis of serial liver biopsies.
Scientific Title:Acronym	Progressing factors of nonalcoholic fatty liver disease(NAFLD)by gene analysis of serial liver biopsies.
Region	Japan

Condition
Condition	Nonalcoholic fatty liver disease (NAFLD) Nonalcoholic steatohepatitis (NASH) Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the relationship between the gene expression of tissues by serial liver biopsies and peripheral blood leukocytes in NAFLD patients.
Basic objectives2	Others
Basic objectives -Others	To establish the new therapeutic target of NAFLD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the relationship between hepatic the gene expression by serial liver biopsies and peripheral blood leukocytes in NAFLD patients.
Key secondary outcomes	1) Histological scoring of samples by serial liver biopsies according to Matteoni classification and Brunt classification 2) Analysis of temporal and histological natural history of NAFLD pathology using Linear Mixed Model 3) Diabetic factors (HbA1c, blood biochemistry data, insulin secretory ability, organ-specific insulin resistance determined by hyperinsulinemic euglycemic clamp, organ specific cellular fat accumulation determined by MRS and impedance method, blood hepatocaine level, Diabetes treatment etc.) related to liver pathology 4) Analysis of the hepatic gene expression by serial liver biopsies and peripheral blood leukocytes in NAFLD patients by next-generation sequencing 5) Principal component analysis of genes belonging to metabolic pathways (glycolysis system, fatty acid oxidation, mitochondrial oxidative phosphorylation, etc.) 6) Hepatic gene expression and variable genes in association with NAFLD pathology 7) Identification of SNPs related to change of liver pathology using DNA in peripheral blood cells 8) Analysis of proteins and metabolites in blood by proteomics, metabolomics and lipidomics 9) Measurement of biomarker candidates of NASH such as M2BPGi, ferritin, inflammatory cytokines

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 old 2. NAFLD patients who underwent more than twice liver biopsies from 1998 to December 31, 2017 3. Patients agreeing with the use in genetic analysis when providing existing samples and information 4. Patients who do not refuse participation by the website
Key exclusion criteria	1.Younger than 20 years old
Target sample size	121

Research contact person
Name of lead principal investigator	1st name Toshinari Middle name Last name Takamura
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Endocrinology and Metabolism
Zip code	920-8641
Address	3-1 Takara-Machi, Kanazawa
TEL	076-265-2234
Email	ttakamura@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Toshinari Middle name Last name Takamura
Organization	Department of Endocrinology and Metabolism, Graduate School of Medical Sciences, Kanazawa University
Division name	Department of Endocrinology and Metabolism
Zip code	920-8640
Address	13-1 Takara-machi
TEL	+81762652711
Homepage URL
Email	ttakamura@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa university hospital Department of Endocrinology and metabolism
Institute
Department

Funding Source
Organization	The Japan Diabetes Society Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Innovative Clinical Research Center, Kanazawa University.
Address	13-1 takaramachi kanazawa
Tel	046-265-2049
Email	hpsangak@adm.kanazawa-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	2018 Year 12 Month 20 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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 10 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 20 Day
Last follow-up date	2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1.Cohort study 2.NAFLD patients who underwent more than two liver biopsies from 1998 to December 31, 2017

Management information
Registered date	2018 Year 12 Month 12 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040048