SMART: Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pioglitazone metformin tablets 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) |
Drug: Pioglitazone metformin tablets
Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study)
|
| Active Comparator: Other drug 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: Other drugs
Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1
|
| Other: Drug-free Drug-free |
Other: Drug-free
Drug-free
|
Outcome Measures
Primary Outcome Measures
- 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 [Through study completion, an average of 96 week.]
Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores)，higher scores mean a worse outcome
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-75 years old, gender and ethnicity are not limited;
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Meet the diagnostic criteria for MAFLD;
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F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
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Be willing to sign informed consent.
Exclusion Criteria:
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Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);
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Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
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According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).
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Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Affiliated Hospital of Hangzhou Normal University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMART