UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035231
Receipt number 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 2021/06/14 14:23:59

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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 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 or person

Institute

Kanazawa university hospital
Department of Endocrinology and metabolism

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040048


Research Plan
Registered date File name

Research case data specifications
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Research case data
Registered date File name