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
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
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
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
