UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of Non-alcoholic fatty liver disease(NAFLD) and Non-alcoholic steatohepatitis(NASH) using the measuring instrument of ethanol metabolism
Title of the study (Brief title)	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	Tomohiko Ohashi
Organization	Aichi Medical University
Division name	Department of hepatology and pancreatology
Address	1-1, Yazakokarimata, Nagagute, Aichi, Japan
TEL	0561-62-3311
Email	byc@aichi-med-u.ac.jp

Public contact
Name of contact person	Tomohiko Ohashi
Organization	Aichi Medical University
Division name	Department of hepatology and pancreatology
Address	1-1, Yazakokarimata, Nagagute, Aichi, Japan
TEL	0561-62-3311
Homepage URL
Email	byc@aichi-med-u.ac.jp

Sponsor
Institute	Department of hepatology and pancreatology, Aichi Medical University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028206