Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for MASLD: The subject must have imaging-confirmed hepatic steatosis and meet at least one of the following five metabolic dysfunctions: (1). BMI >=25 kg/m^2 (>=23 kg/m^2 for Asian populations) or waist circumference >94 cm (male) / >80 cm (female) or adjusted for ethnicity; (2).FBS >=5.6 mmol/L; 2-hour postprandial glucose >=7.8 mmol/L; HbA1c >=5.7%; type 2 diabetes mellitus or on treatment; (3). Blood pressure >=130/85 mmHg or on antihypertensive treatment; (4). Plasma triglycerides >=1.70 mmol/L or on lipid-lowering treatment; (5). Plasma HDL cholesterol =18 years; 3.Body mass index (BMI) >=27 kg/m^2; 4.The subjects were informed and voluntarily participated in the study, were able to understand the study content and signed the written informed consent, and cooperated to complete the 12 week treatment and follow-up; 5.Open the label according to the wishes of the subjects. The doctor and the subjects jointly decide which treatment mode to accept. The decision to accept which treatment is made before participating in this study and has nothing to do with participating in this study.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or breastfeeding; 2.Concurrent chronic liver diseases (chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, autoimmune liver disease, etc.); 3.Malignant tumors (hepatocellular carcinoma, thyroid cancer) with unresolved clinical status; 4.Acute pancreatitis within six months; 5.Patients who have received vitamin E (>=800 IU/day), pioglitazone, GLP-1 agonist analogs, or approved MASH treatments within the past 3 months without reaching a stable dose. 6.weight loss <=5% within 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat attenuation parameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver enzymes?Blood glucose?HbA1c?Insulin ?Blood lipids?Uric acid?Renal function?C-reactive protein?Liver stiffness value?Body weight?BMI?Body fat percentage; | — |
Countries
China
Contacts
The First People's Hospital of Foshan