Clinical Classification of MAFLD Based Liver Biopsy

• Recruitment and Data Collection:

On the basis of an existing cohort of 1,500 liver biopsy cases, recruit an additional 500 cases from a national multicenter liver biopsy follow-up cohort (totaling 2,000 cases). Collect demographic, anthropometric, laboratory, imaging, and liver biopsy results for these patients.

Concurrently, biological samples, including blood, urine, feces, and liver biopsy tissues, will be collected. Utilize these samples to perform quantitative metabolite information based on database matching. Employ techniques such as genomics, epigenomics, proteomics, metabolomics, immunomics, and microbiome metagenomics to screen for differential biomarkers across different subgroups.

Combine these findings with clinical and imaging parameters of MAFLD patients to analyze and explore key parameters and molecules at different stages and outcomes of MAFLD disease progression.

• Development and Validation of a Diagnostic and Prognostic System:

Based on key molecules identified through multi-omics, in conjunction with characteristic parameters from clinical and imaging data of MAFLD patients, use machine learning methods (such as random forests neural networks) combined with logistic regression to establish a novel non-invasive diagnostic and prognostic assessment system for adverse outcomes (cardiovascular events, non-liver malignancies, and liver-related events).

Validate this new assessment system to ensure its reliability and accuracy in predicting disease outcomes.

Inclusion criteria

• Ultrasound confirmation of fatty liver and the presence of at least one of the following metabolic cardiovascular risk factors:

• BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) and 85 cm (women) or excessive body fat content and body fat percentage.
• Fasting blood glucose ≥ 6.1 mmol/L or 2-hour post-load blood glucose ≥ 7.8 mmol/L or HbA1c ≥ 5.7% or history of Type 2 Diabetes Mellitus (T2DM) or Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
• Fasting serum triglycerides ≥ 1.70 mmol/L or currently receiving lipid-lowering drug therapy.
• Serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol/L (men) and 1.3 mmol/L (women) or currently receiving lipid-lowering drug therapy.
• Blood pressure ≥ 130/85 mmHg or currently receiving antihypertensive drug therapy.
• histology of liver-biopsy

Exclusion criteria

• Excessive Alcohol Consumption: Individuals who consume alcohol equivalent to ≥30 grams of ethanol per day for males, or ≥20 grams of ethanol per day for females, or those with missing alcohol consumption information.
• Viral Hepatitis Markers: Individuals who are positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C virus (HCV) antibodies, or have missing information regarding these markers.
• History of Serious Medical Conditions: Individuals with a history of malignant tumors, cardiovascular diseases, chronic kidney disease, decompensated liver cirrhosis (manifested by ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.), or those who have undergone liver transplantation.