UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028735 |
|---|---|
| Receipt number | R000032885 |
| Scientific Title | the effect of alcohol on fatty liver disease. |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2018/08/20 08:39:51 |
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Basic information
Public title
the effect of alcohol on fatty liver disease.
Acronym
the effect of alcohol on fatty liver disease.
Scientific Title
the effect of alcohol on fatty liver disease.
Scientific Title:Acronym
the effect of alcohol on fatty liver disease.
Region
| Japan |
Condition
Condition
fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to analyze the relationship between alcoholic intake and fatty liver disease.
Basic objectives2
Others
Basic objectives -Others
the factors associated with development fatty liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the cut off value of alcoholic intake of development fatty liver disease.
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese individuals who participated in
health checkups, or patients who underwent liver biopsy.
Key exclusion criteria
(1) patients positive for hepatitis B
surface antigen and hepatitis C virus antibody, (2) patients
under treatment for thyroid disease or hormone therapy
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUYA SEKO |
Organization
Kyoto Prefectural University of Medeicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515519
yuyaseko@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUYA SEKO |
Organization
Kyoto Prefectural University of Medeicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515519
Homepage URL
yuyaseko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medeicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medeicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 09 | Month | 30 | 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
| 2017 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the aim of this study is to analyze the association between alcoholic intake and fatty liver disease.
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
