Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies (SMART)

The Affiliated Hospital of Hangzhou Normal University

Status: Not yet enrolling

Conditions: Cirrhosis; Metabolic Dysfunction-associated Fatty Liver Disease

Treatments: Other: Drug-free; Drug: Other drugs; Drug: Pioglitazone metformin tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06135584

SMART

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75 years old, gender and ethnicity are not limited;
2. Meet the diagnostic criteria for MAFLD;
3. F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
4. Be willing to sign informed consent.

Exclusion criteria

1. 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);
2. Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
3. 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).
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Pioglitazone metformin tablets

Experimental group

Description:

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)

Treatment:

Drug: Pioglitazone metformin tablets

Other drug

Active Comparator group

Description:

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)

Treatment:

Drug: Other drugs

Drug-free

Other group

Description:

Drug-free

Treatment:

Other: Drug-free