UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030687 |
|---|---|
| Receipt number | R000035038 |
| Scientific Title | Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2020/06/15 09:06:19 |
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Basic information
Public title
Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Acronym
Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Scientific Title
Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Scientific Title:Acronym
Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Region
| Japan |
Condition
Condition
A healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Breath endogenous alcohol and acetaldehyde concentrations
Key secondary outcomes
ADH1B and ALDH2 genotypes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention is straight for 2 days. A subject is sampled his/her breath 4 times for the 2 days; on rising (5:00~7:00), before lunch (11:00~13:00), before dinner (17:00~19:00) and before retiring (23:00~25:00). Sampling is taken after at least 3 h of fasting and 1 h of washing mouth. A subject abstains from alcohol during intervention.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･20<= years-old
･Male and Female
･A person who is provided sufficient explanations about this study and consented to it in writing by his/her own free will
Key exclusion criteria
･an inappropriate person for this study
･a person who has any airway diseases or liver diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, JAPAN
TEL
0836-22-2234
fujimiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, JAPAN
TEL
0836-22-2234
Homepage URL
haku.a@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
None
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
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, JAPAN
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
| 2018 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
