Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD

Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD - Non-interventional prospective observational study: changes in hepatic profile with standard treatment of hypertriglyceridemia-associated MASLD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052895

Enrollment

Registered

2023-11-24

Start date

2023-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia complicated MASLD

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

Exclusion criteria: Cases in which written consent to participate in the study cannot be obtained.

Design outcomes

Primary

Measure	Time frame
Changes in liver histology (fibrosis stage and NAS) from time of enrollment to 52 weeks or later.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTakefumi Kimura

Shinshu University Gastroenterology

t_kimura@shinshu-u.ac.jp81263372644

Outcome results