UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027399 |
|---|---|
| Receipt number | R000031398 |
| Scientific Title | The effect of metabolic syndrome and associated genetic factors on fatty liver disease |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/05/22 10:08:04 |
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Basic information
Public title
The effect of metabolic syndrome and associated genetic factors on fatty liver disease
Acronym
metabolic syndrome-related genetic factors on fatty liver
Scientific Title
The effect of metabolic syndrome and associated genetic factors on fatty liver disease
Scientific Title:Acronym
metabolic syndrome-related genetic factors on fatty liver
Region
| Japan |
Condition
Condition
Non alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
the aim of this study is to estimate the frequencies and impact of genetic factors such as PNPLA3, NCAN, LYPLL1, GCKR, PPP1R3b, CYP17A1, NT5C2, ADIPOQ, TM6SF2 and TLL1 to the pathology of patients with fatty liver disease.
Basic objectives2
Others
Basic objectives -Others
the effect of SNPs to hepatic histological change.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the frequencies of SNPs and the effect on hepatic histological findings
Key secondary outcomes
the effect on prognosis.
the effect on malignancies.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients receiving medical checkups in our department.
Key exclusion criteria
patients with hepatitis B surface antigen-positive and hepatitis C virus antibody-positive, 2) ongoing treatment for thyroid disease, hormone therapy,
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | kanji Yamaguchi |
| Middle name | |
| Last name | Kanji Yamaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
6028566
Address
Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL
+81-75-251-5519
yuyaseko@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | yuya seko |
| Middle name | |
| Last name | Yuya Seko |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
6028566
Address
Kawaramachi-Hirokoji, Kamigyou-ku, Kyoto
TEL
+81-75-251-5519
Homepage URL
yuyaseko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku
Tel
0752515519
rinri@koto.kpu-m.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
| 2018 | Year | 04 | Month | 01 | 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
| 2016 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the association between the variants of SNPs and histological changing.
Management information
Registered date
| 2017 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031398
| Research Plan | |
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| 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 |
