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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group of NASH-related liver fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of NASH fibrosis | Regression of NASH fibrosis based on liver biopsy | 1-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic changes of liver stiffness measurements (LSM) | Dynamic changes of liver stiffness measurements (LSM) | 3 years |
| Dynamic changes of Controlled Attenuation Parameter (CAP) | Dynamic changes of CAP, higher scores mean a worse outcome. |
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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;
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NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yameng Sun, M.D. | Contact | 86-010-63138656 | sunyamenggo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jidong Jia, Professor | Beijing Friendship Hospital | Principal Investigator |
| Jingmin Zhao, Professor | Beijing 302 Hospital | Principal Investigator |
| Jing Zhang |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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|
| 3 years |
| Dynamic changes of Magnetic Resonance Elastography (MRE) | Dynamic changes of MRE, higher scores mean a worse outcome. | 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. | 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. | 3 years |
| Dynamic changes of non-invasive liver fibrosis models | Dynamic changes of Fibrosis-4 Index (FIB-4), higher scores mean a worse outcome. | 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. | 3 years |
| Dynamic changes of non-invasive liver fibrosis models | Dynamic changes of NAFLD Fibrosis Score (NFS), higher scores mean a worse outcome. | 3 years |
| Dynamic changes of non-invasive liver fibrosis models | Dynamic changes of FibroScan-aspartate aminotransferase score (FAST), higher scores mean a worse outcome. | 3 years |
| Dynamic changes of metabolic markers | Dynamic changes of Body Mass Index (BMI), higher scores mean a worse outcome. | 3 years |
| Dynamic changes of metabolic markers | Dynamic changes of fasting glucose | 3 years |
| Dynamic changes of metabolic markers | Dynamic changes of serum lipid level | 3 years |
| Incidence of liver-related events | Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation | 3 years |
| Incidence of extrahepatic related events | Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases | 3 years |
| Beijing You-an Hospital, Capital Medical University |
| Principal Investigator |
| Minghui Li | Beijing Ditan Hospital | Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |