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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009614
Receipt No. R000011278
Scientific Title Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality
Date of disclosure of the study information 2012/12/25
Last modified on 2013/12/27

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Basic information
Public title Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality
Acronym Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event
Scientific Title Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event in terms of lipid metabolism abnormality
Scientific Title:Acronym Analysis of nonalcoholic steatohepatitis and the risk of cardiovascular event
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 To evaluate the risk of cardiovascular event in nonalcoholic fatty liver disease in terms of lipid metabolism abnormality and whether the lipid-lowering drug reduces the risk of cardiovascular event in nonalcoholic fatty liver disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Small dense LDL cholesterol and non-HDL cholesterol
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 control
Interventions/Control_2 lipid-lowering drug
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
70 years-old >
Gender Male and Female
Key inclusion criteria Patients with NAFLD diagnosed by liver biopsy
Key exclusion criteria Subjects with a history of excessive alcohol consumption (>140 g/week for men, >70 g/week for women), other liver diseases, drug use associated with fatty liver, or weight reduction were excluded
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2640
Email kento318@yohokama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kento Imajo
Organization Yokohama City University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 3-9, Fuku-ura, Kanazawaku, Yokohama city
TEL 045-787-2640
Homepage URL
Email kento318@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
2012 Year 12 Month 25 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 Completed
Date of protocol fixation
2012 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 24 Day
Last follow-up date
2013 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 12 Month 16 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 22 Day
Last modified on
2013 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011278

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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