UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040862 |
|---|---|
| Receipt number | R000046635 |
| Scientific Title | Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2021/04/05 21:54:53 |
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Basic information
Public title
Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Acronym
Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Scientific Title
Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Scientific Title:Acronym
Consumption of cholesterol in nonalcoholic fatty liver disease (NAFLD): A multicenter cross sectional study
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess the consumption of cholesterol in relation to disease progression with Japanese NAFLD patients.
Basic objectives2
Others
Basic objectives -Others
The relation between the consumption of cholesterol and the liver fibrosis, steatosis, inflammation, and hepatocellular ballooning
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the relation between the consumption of cholesterol and the liver fibrosis, steatosis, inflammation, and hepatocellular ballooning which were diagnosed with liver biopsy
Key secondary outcomes
To assess the relation between the consumption of cholesterol and AST, ALT, GTP, liver stiffness measurement, bile acid composition, and sterol oxidations
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) NAFLD patients who were diagnosed with liver biopsy within 1 year before a written informed consent.
(2) Alcohol consumption (ethanol equivalent volume), <30 g/day for men, <20 g/day for women.
Key exclusion criteria
(1) History of chronic hepatic disease (viral hepatic disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
(2) Hepatocellular carcinoma and other malignant diseases
(3) Patients judged inappropriate by doctor or investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kamada |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Molecular Biochemistry & Clinical Investigation
Zip code
565-0871
Address
2-2 K1, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
ykamada@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Iwaki |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL
045-787-2640
Homepage URL
michihir@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Molecular Biochemistry & Clinical Investigation, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University
Department of Gastroenterology, JA Hiroshima General Hospital
Department of Gastroenterology and Metabolism, Institute of Biomedical & Health Sciences, Hiroshima University
Division of Cardiovascular Medicine, Department of Medicine, Osaka University Graduate School of Medicine
Maeda Clinic
Department of Health and Nutrition Sciences,Faculty of Human Life Sciences, Nagoya Keizai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University Hospital
Address
5-1-1, Nabeshima, Saga
Tel
0952-34-3010
takahas2@cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-03-02
Org. issuing International ID_1
Saga University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | 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
Other related information
This study is observational study.
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046635
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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