Metabolic Dysfunction-associated Fatty Liver Disease, Cirrhosis
Conditions
Keywords
Treatment Strategies, Multicenter Real-World Study
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.
Interventions
DRUGPioglitazone 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)
DRUGOther drugs
Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1
OTHERDrug-free
Drug-free
Sponsors
The Affiliated Hospital of Hangzhou Normal University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Contacts
Primary ContactJunping Shi, Doctor
Backup ContactJing Liu
Outcome results
None listed