UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052895 |
|---|---|
| Receipt number | R000060355 |
| Scientific Title | Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/24 18:14:22 |
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Basic information
Public title
Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD
Acronym
Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD
Scientific Title
Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD
Scientific Title:Acronym
Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD
Region
| Japan |
Condition
Condition
Hypertriglyceridemia complicated MASLD
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to prospectively identify clinical markers and hepatic pathological changes in hypertriglyceridemia-associated MASLD as affected by the current standard treatment of hypertriglyceridemia: diet, exercise, and fibrate therapy.
Basic objectives2
Others
Basic objectives -Others
The objective is to prospectively identify changes in liver signaling pathways in hypertriglyceridemia-associated MASLD as affected by current standard therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in liver histology (fibrosis stage and NAS) from time of enrollment to 52 weeks or later.
Key secondary outcomes
Percentage and amount of change in laboratory values from enrollment to 52 weeks or later (TG, TC, HDL-C, LDL-C (direct method), WBC, RBC, Hb, Plt, PT%, TP, Alb, BUN, Cre, eGFR, Na, K, Cl, T-Bil, D-Bil, I-Bil, AST, ALT, AFP, AFP- L3, PIVKA-II, type 4 C7S, M2BPGi, Autotaxin, etc.),Changes in imaging findings from enrollment to 52 weeks or later: CT values, MRI (PDFF values, elastography values) US (presence of fatty liver), Fibroscan (CAP values, E values),Changes in body composition from the time of enrollment to 52 weeks or later: InBody,Liver signaling pathway (Single-nucleus RNA-seq analysis, Quantitative PCR, Western blotting, immunohistochemistry),Adverse events.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertriglyceridemic patients between the ages of 20 and 80 years who have been diagnosed with MASLD by the NASH Clinical Research Network classification on liver biopsy and whose disease status will be evaluated by multiple liver biopsies.
Patients who meet the above criteria and have started standard treatment (diet, exercise, and fibrate therapy).
Key exclusion criteria
Cases in which written consent to participate in the study cannot be obtained.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeji |
| Middle name | |
| Last name | Umemura |
Organization
Shinshu University
Division name
Gastroenterology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
81263372644
t-umemura@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takefumi |
| Middle name | |
| Last name | Kimura |
Organization
Shinshu University
Division name
Gastroenterology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
81263372644
Homepage URL
t_kimura@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Ethics Committee
Address
3-1-1 Asahi-, Matsumoto City, Nagano Prefecture
Tel
81263372644
t_kimura@shinshu-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 | 11 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conducted at Shinshu University.
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060355
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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