metabolic associated fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Definitive diagnosis of type 2 diabetes mellitus (meeting clinically accepted diagnostic criteria); 3. Baseline BMI >=24 kg/m², or being recorded as overweight/obese in outpatient records; 4. Imaging findings or clinical data supporting the presence of fatty liver disease or metabolic associated steatohepatosis (MASH); 5. Disposition of routine laboratory tests and physical measurements within 30 days prior to and following timepoint T0 (the outpatient evaluation point determining whether further liver fibrosis stratification testing is warranted); 6. Completion of at least one reference-standardized liver fibrosis assessment method (e.g., transient elastography or magnetic resonance elastography) within 180 days after timepoint T0.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of viral hepatitis, autoimmune liver disease, significant alcohol-related liver disease, or other known non-metabolic chronic liver diseases; 2. History of decompensated cirrhosis, hepatocellular carcinoma, or liver transplantation; 3. Pregnancy status, presence of active malignant tumors, or other severe systemic diseases significantly affecting liver function and metabolic status; 4. Lack of core baseline variables (e.g., waist circumference, HbA1c, AST, ALT) or inability to obtain reference standard outcomes (such as liver fibrosis assessment results).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FibroScan Controlled Attenuation Parameter (CAP);Liver Hardness Value (LSM);sensitivity;specificity; | — |
Countries
China
Contacts
Xinqiao Hospital, Shapingba District, Chongqing, China