Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lifestyle intervention.
- Who it may be relevant to
- Registry conditions: NASH, Liver Fibrosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
Overview
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.
Interventions
- Other lifestyle intervention
Dietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence.
Primary outcome measures
- Regression of NASH fibrosis [Time frame: 1-3 years]
Secondary outcome measures (12)
- Dynamic changes of liver stiffness measurements (LSM) [Time frame: 3 years]
- Dynamic changes of Controlled Attenuation Parameter (CAP) [Time frame: 3 years]
- Dynamic changes of Magnetic Resonance Elastography (MRE) [Time frame: 3 years]
- Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) [Time frame: 3 years]
- Dynamic changes of non-invasive liver fibrosis models [Time frame: 3 years]
- Dynamic changes of non-invasive liver fibrosis models [Time frame: 3 years]
- Dynamic changes of non-invasive liver fibrosis models [Time frame: 3 years]
- Dynamic changes of non-invasive liver fibrosis models [Time frame: 3 years]
- Dynamic changes of non-invasive liver fibrosis models [Time frame: 3 years]
- Dynamic changes of metabolic markers [Time frame: 3 years]
- Dynamic changes of metabolic markers [Time frame: 3 years]
- Dynamic changes of metabolic markers [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 18-70 years of age.
- Liver biopsy-proven NASH fibrosis with stage F2-4.
- Signature of written informed consent.
Exclusion criteria
- Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.
- Pregnant women.
- Patients have the following conditions before liver biopsy:
Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;
- Patients with any other reasons not suitable for the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06364462 · ZLRK202301