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Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | After successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep/wake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| life-style | Other | The patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of NASH liver fibrosis | Reversal of NASH liver fibrosis based on liver biopsy definition | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in LSM value | Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing | 12 months |
| Changes in liver fat content | Instantaneous liver elasticity detection of changes in liver fat content (CAP value) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minghui Li | Contact | +8613693259096 | wuhm2000@sina.com | |
| Weihua Cao | Contact | +8618811333129 | weihuacaohappy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 12 months |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10^9/L)×100 | 12 months |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | The dynamic changes of existing non-invasive evaluation models for fibrosis include: FIB-4: Age, AST, ALT, platelets | 12 months |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | The dynamic changes of existing non-invasive evaluation models for fibrosis include: BARD:BMI ≥28, AST/ALT ≥0.8, diabetes | 12 months |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | The dynamic changes of existing non-invasive evaluation models for fibrosis include: NAFLD Fibrosis Score | 12 months |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | The dynamic changes of existing non-invasive evaluation models for fibrosis include: FAST | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including BMI; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including body fat percentage; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including blood pressure; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including sugar; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including glycated hemoglobin; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including fasting insulin; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including uric acid; | 12 months |
| Dynamic changes in metabolic indicators of NAFLD | Dynamic changes in metabolic indicators of NAFLD, including blood lipid series; | 12 months |
| The occurrence of cirrhosis | The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up. | 12 months |
| The occurrence of liver outcome events | The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation. | 12 months |
| Extrahepatic related events | Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases. | 12 months |