UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043266 |
|---|---|
| Receipt number | R000049383 |
| Scientific Title | A cross-sectional study on the significance of measuring amino acids in understanding the pathogenesis of non-alcoholic fatty liver disease |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/06 19:06:18 |
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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
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
michihir@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049383
| 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 |
