Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

N/ANot Yet RecruitingNCT06364462

Beijing Friendship Hospital220 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

NASH Liver Fibrosis

Interventions

lifestyle interventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Regression of NASH fibrosis

Regression of NASH fibrosis based on liver biopsy

Time frame: 1-3 years

Secondary Outcomes

Dynamic changes of liver stiffness measurements (LSM)

Time frame: 3 years

Dynamic changes of Controlled Attenuation Parameter (CAP)

Dynamic changes of CAP, higher scores mean a worse outcome.

Time frame: 3 years

Dynamic changes of Magnetic Resonance Elastography (MRE)

Dynamic changes of MRE, higher scores mean a worse outcome.

Time frame: 3 years

Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)

Dynamic changes of MRI-PDFF, higher scores mean a worse outcome.

Time frame: 3 years

Dynamic changes of non-invasive liver fibrosis models

Dynamic changes of Aspartate Aminotransferase to Platelet Ratio Index (APRI), , higher scores mean a worse outcome.

Time frame: 3 years

Dynamic changes of non-invasive liver fibrosis models

Dynamic changes of Fibrosis-4 Index (FIB-4), higher scores mean a worse outcome.

Time frame: 3 years

Dynamic changes of non-invasive liver fibrosis models

Dynamic changes of BARD (BMI, AST/ALT Ratio, Diabetes), higher scores mean a worse outcome.

Central Contacts

Yameng Sun, M.D.

CONTACT

86-010-63138656 sunyamenggo@163.com

Data from ClinicalTrials.gov

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