UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042694 |
|---|---|
| Receipt number | R000048722 |
| Scientific Title | Study on the relationship between the breath acetaldehyde/ethanol ratio and the severity of NAFLD |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2020/12/08 23:32:21 |
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Basic information
Public title
Study on the relationship between the breath acetaldehyde/ethanol ratio and the severity of NAFLD
Acronym
Relationship between the breath acetaldehyde/ethanol ratio and NAFLD
Scientific Title
Study on the relationship between the breath acetaldehyde/ethanol ratio and the severity of NAFLD
Scientific Title:Acronym
Relationship between the breath acetaldehyde/ethanol ratio and NAFLD
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The relationship between SNPs of ethanol metabolism and NAFLD, history of drinking, A/E ratio, NAFLD severity (FIB-4 index and Fibroscan) is examined.
Basic objectives2
Others
Basic objectives -Others
Relationship between SNPs and NAFLD severity
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between A/E ration and NAFLD severity
Key secondary outcomes
Relationship between SNPs and NAFLD severity
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
1. NAFLD patients who will receive FibroScan
2. Age over 20 yrs
3. AST, ALT, GGT under 5 ULN
4. alcohol intake
male: less than 30g/day (210g/wk)
female: less than 20g/day (140g/wk)
5. patients who cannot consent
Key exclusion criteria
1. allelgy for alcohol
2. pregnant or breast-feeding women
3. severe complication
4. patients with pacemaker
5. HBV or HCV infection
6. history of Gastrointestinal surgery
7. enrolling at other studies
8. not applicable by judgment of physicians
9. decompensated cirrhosis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yoneda |
Organization
Aichi Medical University
Division name
Department of Hepatology and Pancreatology
Zip code
4801195
Address
Yazako Karimata 1-1, Nagakute, Aichi
TEL
0561-62-3311
yoneda@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Sumida |
Organization
Aichi Medical University
Division name
Department of Hepatology and Pancreatology
Zip code
4801195
Address
Yazako Karimata 1-1, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
sumida@koto.kpu-m.ac.jp
Sponsor or person
Institute
kyoto University
Institute
Department
Personal name
Funding Source
Organization
kyoto university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shimane University, Ishikawa prefectural University,Kagoshima University, Okayam Univerisity, Kumamoto Univerisity
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
Yazako Karimata 1-1, nagakute, Aichi
Tel
0561-62-3311
sumida,yosho.500@mail.aichi-med-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
島根大学医学部附属病院 第二内科 (島根県）
石川県立中央病院 消化器内科 （石川県）
鹿児島大学病院 消化器内科 （鹿児島県）
岡山大学病院 消化器内科 （岡山県）
熊本大学病院 消化器内科 （熊本県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 10 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2000 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048722
