UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052241 |
|---|---|
| Receipt number | R000059634 |
| Scientific Title | Liver microenvironment changes caused by fat accumulation influence the hepatic Mac-2-binding protein expression in patients with NAFLD |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2023/09/19 15:40:28 |
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Basic information
Public title
Liver microenvironment changes caused by fat accumulation influence the hepatic Mac-2-binding protein expression in patients with NAFLD
Acronym
Liver microenvironment changes caused by fat accumulation influence the hepatic Mac-2-binding protein expression in patients with NAFLD
Scientific Title
Liver microenvironment changes caused by fat accumulation influence the hepatic Mac-2-binding protein expression in patients with NAFLD
Scientific Title:Acronym
Liver microenvironment changes caused by fat accumulation influence the hepatic Mac-2-binding protein expression in patients with NAFLD
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate how liver microenvironment changes caused by fat accumulation influence the hepatic expression of Mac-2-binding protein (M2BP) in patients with nonalcoholic fatty liver disease (NAFLD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The endpoint was to evaluate the influence of NAS and fibrosis to the hepatic M2BP expression
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From January 2015 to May 2022, 50 patients with pathologically confirmed NAFLD were enrolled at a single center in Japan.
Key exclusion criteria
Patients with a type of cancer other than hepatocellular carcinoma (HCC) were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-47-372-3501
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
Kitasato University School of Medicine
TEL
+81-47-372-3501
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School 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
Institutional Review Board of kitasato university
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
Tel
0427788111
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 19 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Whether serum M2BPGi levels are correlated with fibrosis caused by other etiologies, such as nonalcoholic fatty liver disease (NAFLD), is unclear.
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059634
