Liver Fibrosis, NASH
Conditions
Keywords
NASH, Liver fibrosis
Brief summary
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
OTHERlifestyle 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.
Sponsors
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression of NASH fibrosis | 1-3 years | Regression of NASH fibrosis based on liver biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic changes of liver stiffness measurements (LSM) | 3 years | Dynamic changes of liver stiffness measurements (LSM) |
| Dynamic changes of Controlled Attenuation Parameter (CAP) | 3 years | Dynamic changes of CAP, higher scores mean a worse outcome. |
| Dynamic changes of Magnetic Resonance Elastography (MRE) | 3 years | Dynamic changes of MRE, higher scores mean a worse outcome. |
| Dynamic changes of metabolic markers | 3 years | Dynamic changes of Body Mass Index (BMI), higher scores mean a worse outcome. |
| Dynamic changes of non-invasive liver fibrosis models | 3 years | Dynamic changes of Aspartate Aminotransferase to Platelet Ratio Index (APRI), , higher scores mean a worse outcome. |
| Incidence of liver-related events | 3 years | Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation |
| Incidence of extrahepatic related events | 3 years | Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases |
| Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | 3 years | Dynamic changes of MRI-PDFF, higher scores mean a worse outcome. |
Contacts
Primary ContactYameng Sun, M.D.
Outcome results
None listed