Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-70 years of age.
Liver biopsy-proven NASH fibrosis with stage F2-4.
Signature of written informed consent.
Disqualifiers
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 with any other reasons not suitable for the study.
Trial population
NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
lifestyle intervention
Other interventionDietary 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.
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: Observational group of NASH-related liver fibrosis1 intervention
Trial outcomes
Primary outcomes
1
Regression of NASH fibrosis
Regression of NASH fibrosis based on liver biopsy
Time frame
1-3 yearsSecondary outcomes
1
Dynamic changes of liver stiffness measurements (LSM)
Dynamic changes of liver stiffness measurements (LSM)
Time frame
3 years2
Dynamic changes of Controlled Attenuation Parameter (CAP)
Dynamic changes of CAP, higher scores mean a worse outcome.
Time frame
3 years3
Dynamic changes of Magnetic Resonance Elastography (MRE)
Dynamic changes of MRE, higher scores mean a worse outcome.
Time frame
3 years4
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 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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