UMIN-CTR Clinical Trial

Basic information
Public title	A cross-sectional study on measuring amino acids in fatty liver
Acronym	A study to measure amino acids in fatty liver
Scientific Title	A cross-sectional study on the significance of measuring amino acids in understanding the pathogenesis of non-alcoholic fatty liver disease
Scientific Title:Acronym	A study to measure amino acids in non-alcoholic fatty liver disease
Region	Japan

Condition
Condition	non-alcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To search for biomarkers of development of nonalcoholic fatty liver disease (NAFLD), we will analyze D-amino acids and L-amino acids in serum and stool of patients with NAFLD
Basic objectives2	Others
Basic objectives -Others	The identification of characteristic composition of D- and L-body amino acids in nonalcoholic fatty liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of serum and fecal amino acid concentrations between NAFLD and non-NAFLD patients
Key secondary outcomes

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed with NAFLD by histological or imaging studies within 6 months. Patients who have not been diagnosed with NAFLD by imaging studies such as ultrasonography and MRI within 6 months.
Key exclusion criteria	Patients who have used antimicrobial agents within one month of blood and stool specimen collection Patients who have been diagnosed with infectious hepatitis (hepatitis B or C, HIV infection), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced hepatitis, alcoholic hepatitis, or are known to consume excessive amounts of alcohol Patients who are unable to collect specimens due to defecation disorder. Patients who do not wish their medical information to be used for research purposes. Patients who are judged by the physician to be unsuitable for the study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Michihiro Middle name Last name Iwaki
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872800
Email	michihir@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Michihiro Middle name Last name Iwaki
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872800
Homepage URL
Email	michihir@yokohama-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Yokohama City University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Drug Discovery Department, Chemistry Research Group, EA Pharma Co., Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama city university, Institutional Review Board for Medical and Health Research Involving Human Subjects
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel	0457872640
Email	rinri@yokohama-cu.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	2021 Year 02 Month 08 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	Open public recruiting
Date of protocol fixation	2021 Year 02 Month 05 Day
Date of IRB	2021 Year 02 Month 05 Day
Anticipated trial start date	2021 Year 02 Month 06 Day
Last follow-up date	2026 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	study design: Cross sectional study Items to measure: blood biochemical tests, urinalysis, tissue examination by liver biopsy, Liver stiffness and liver fat content by MRI, Amino acids in stool and blood, Intestinal bacteria analysis, Metabolite analysis in stool

Management information
Registered date	2021 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049383