UMIN-CTR Clinical Trial

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
Email	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
Email	sumida@koto.kpu-m.ac.jp

Sponsor
Institute	kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048722