UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024594 |
|---|---|
| Receipt number | R000028206 |
| Scientific Title | Research of Non-alcoholic fatty liver disease(NAFLD) and Non-alcoholic steatohepatitis(NASH) using the measuring instrument of ethanol metabolism |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/10/27 16:46:11 |
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Basic information
Public title
Research of Non-alcoholic fatty liver disease(NAFLD) and Non-alcoholic steatohepatitis(NASH) using the measuring instrument of ethanol metabolism
Acronym
Research of NAFLD and NASH using the measuring instrument of ethanol metabolism
Scientific Title
Research of Non-alcoholic fatty liver disease(NAFLD) and Non-alcoholic steatohepatitis(NASH) using the measuring instrument of ethanol metabolism
Scientific Title:Acronym
Research of NAFLD and NASH using the measuring instrument of ethanol metabolism
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease(NAFLD)
Non-alcoholic steatohepatitis(NASH)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate whethet small amount of alcohol contributes to the pathogenesis of NAFLD and NASH using the breath ethanol metabolism analyzer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of expiration ethanol/acetaldehyde density after small amount of alcohol drinking
Key secondary outcomes
Genotype of aldehyde dehydrogenase
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
To intake of 0.5g Ethanol 100ml only once
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
non-alcoholic fatty liver disease
non-alcoholic steatohepatitis
Key exclusion criteria
under 20 years of age
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Ohashi |
Organization
Aichi Medical University
Division name
Department of hepatology and pancreatology
Zip code
Address
1-1, Yazakokarimata, Nagagute, Aichi, Japan
TEL
0561-62-3311
byc@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Ohashi |
Organization
Aichi Medical University
Division name
Department of hepatology and pancreatology
Zip code
Address
1-1, Yazakokarimata, Nagagute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
byc@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of hepatology and pancreatology, Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of hepatology and pancreatology, Aichi Medical University
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
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
| 2016 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028206
