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To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone metformin tablets | Experimental | Pioglitazone metformin tablets 15mg/500mg (To control the fasting blood glucose below 7.0mmol/l, adjust the dose and dosage according to the blood glucose) |
|
| Other drug | Active Comparator | Chinese patent medicine or Hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin and GLP1 ((To control the fasting blood glucose below 7.0mmol/l) |
|
| Drug-free | Other | Drug-free |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone metformin tablets | Drug | Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study) |
| Measure | Description | Time Frame |
|---|---|---|
| Controlled attenuation parameter (CAP) | Through study completion, an average of 96 week. | |
| Transient elastography | Through study completion, an average of 96 week. | |
| Model for end-stage liver disease score | Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores),higher scores mean a worse outcome | Through study completion, an average of 96 week. |
| Portalvein pressure gradient(HVPG) | Through study completion, an average of 96 week. | |
| Prevalence of cirrhosis | Through study completion, an average of 96 week. | |
| Prevalence of liver transplantation | Through study completion, an average of 96 week. | |
| Prevalence of decompensated cirrhosis | Through study completion, an average of 96 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junping Shi, Doctor | Contact | 15869151180 | 20181580@hznu.edu.cn | |
| Jing Liu | Contact | 15869151180 | 20181580@hznu.edu.cn |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other drugs | Drug | Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1 |
|
| Drug-free | Other | Drug-free |
|