NCT Number: NCT06364462
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;
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.
Time frame: 1-3 years
Regression of NASH fibrosis based on liver biopsy
Time frame: 3 years
Dynamic changes of liver stiffness measurements (LSM)
Time frame: 3 years
Dynamic changes of CAP, higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of MRE, higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of MRI-PDFF, higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of Aspartate Aminotransferase to Platelet Ratio Index (APRI), , higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of Fibrosis-4 Index (FIB-4), higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of BARD (BMI, AST/ALT Ratio, Diabetes), higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of NAFLD Fibrosis Score (NFS), higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of FibroScan-aspartate aminotransferase score (FAST), higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of Body Mass Index (BMI), higher scores mean a worse outcome.
Time frame: 3 years
Dynamic changes of fasting glucose
Time frame: 3 years
Dynamic changes of serum lipid level
Time frame: 3 years
Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation
Time frame: 3 years
Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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