on-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD
Not Applicable
Recruiting
- Conditions
- Hypertriglyceridemia complicated MASLD
- Registration Number
- JPRN-UMIN000052895
- Lead Sponsor
- Shinshu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Cases in which written consent to participate in the study cannot be obtained.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in liver histology (fibrosis stage and NAS) from time of enrollment to 52 weeks or later.
- Secondary Outcome Measures
Name Time Method 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.