UMIN-CTR Clinical Trial

Public title

Observational study of lipid profile and lipid metabolism-related factors in chronic liver disease

Acronym

Lipid analysis for chronic liver disease

Scientific Title

Lipid metabolism and lipidomics analysis in patients with chronic liver disease: Multicenter cross-sectional study

Scientific Title:Acronym

Lipidomics analysis for chronic liver disease

Region

Japan

Condition

Non-viral chronic liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Pathophysiology analysis of chronic liver disease using lipidomics and lipid metabolism analysis

Basic objectives2

Others

Basic objectives -Others

Correlation of lipid profile in serum and liver tissue

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Differences in lipid profile among chronic liver disease

Key secondary outcomes

Differences in lipid metabolism and metabolites in each chronic liver disease

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Age is 20 years or older at the time of consent acquisition
2) Those who have received sufficient explanation before participating in this research, and after sufficient understanding, have obtained the voluntary written consent of the research subject.

Key exclusion criteria

1) Those who have difficulty obtaining consent from the person
2) Those who are judged by the principal investigator to be inappropriate as research subjects

Target sample size

50

Name of lead principal investigator

1st name	Kazuyoshi
Middle name
Last name	KON

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

1138421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

kazukon@juntendo.ac.jp

Name of contact person

1st name	Kazuyoshi
Middle name
Last name	KON

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

1138421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

kazukon@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

OSAKE-NO-KAGAKU

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo Clinical Research and Trial Center

Address

3-1-3 Hongo Bunkyo-ku, Tokyo

Tel

03-5802-1584

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2021

Year

05

Month

07

Day

Date of IRB

2021

Year

05

Month

07

Day

Anticipated trial start date

2021

Year

05

Month

07

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 related information

Observation details:
(1) Obtain consent from patients with chronic liver disease and patients with metastatic liver disease who are scheduled to undergo liver biopsy or hepatectomy at our hospital and participating facilities.
(2) Patient background of each case, hematological data, Fibroscan test value, Inbody body composition value, presence / absence of liver cancer, course of treatment for metabolic syndrome-related diseases (dyslipidemia, hypertension, diabetes) Gather information about, nutrition, and drinking history.
(3) After obtaining consent, collect blood and serum for research at the same time before and after liver biopsy. In addition, one puncture sample is collected as a research sample at the time of liver biopsy. For surgery, a part of the liver tissue excised for diagnosis and treatment is used.
(4) Using the serum and liver tissue collected for research, perform target analysis (lipidomics analysis) of lipid composition using liquid chromatography + mass spectrometer in the laboratory of Juntendo University. DNA is extracted from the leukocyte fraction of the collected blood, DNA methylation (epigenome analysis) of lipid metabolism-related genes is performed by the bisulfite sequence method, and it has been said that it is related to the pathological condition of NAFLD by real-time PCR method. Single nucleotide polymorphisms (MBOAT7, PNPLA3, TM6SF2) and lipid-metabolizing enzymes FADS1 and FADS2 will be analyzed. In addition, unstained paraffin sections are prepared from liver biopsy tissue and immunohistochemically stained.

Registered date

2021

Year

06

Month

28

Day

Last modified on

2021

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051025