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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035231
Receipt No. R000040048
Scientific Title Progressing factors of nonalcoholic fatty liver disease(NAFLD)by gene analysis of serial liver biopsies.
Date of disclosure of the study information 2018/12/20
Last modified on 2018/12/12

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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
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Sciences
Division name Department of Endocrinology and Metabolism
Zip code
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
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Sciences
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 Takara-Machi, Kanazawa
TEL 076-265-2234
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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
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
2018 Year 12 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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