Metabolically associated fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Those who met the diagnostic criteria for metabolically related fatty liver disease: The diagnostic criteria for MAFLD were based on histological (liver biopsy), imaging, and blood biomarker evidence of hepatic fat accumulation (hepatocellular steatosis) combined with one of the following three conditions: overweight/obesity, type 2 diabetes, and metabolic dysfunction. 2. Age 18-65 years old; 3. Ultrasound indicated that the fat content was > 30%; BMI <35 kg/m2; 4. Be willing and able to follow predetermined visit plans, diet and exercise instructions, laboratory tests, and other research procedures. 5. Serum alanine aminotransferase (ALT) is less than or equal to 2 times the normal upper limit;
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients who used other liver protection and enzyme lowering drugs in the past 1 month and affected the efficacy evaluation; 2. Patients who took tamoxifen, ethamiodarone, sodium valproate, methotrexate, glucocorticoid and other drugs in the past 3 months to affect lipid metabolism; 3. Special cases of fatty liver caused by total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, ß-lipoprotein deficiency, lipid atrophic diabetes, Mauriac syndrome, etc.; 4. Alcoholic fatty liver (alcohol intake >30g/d for men, alcohol intake >20g/d for women), cirrhosis, hepatitis B, hepatitis C and other liver diseases, autoimmune liver disease, or liver decompensation; 5. Patients with type 2 diabetes with unstable control (HbA1c=9.5% within 1 month before enrollment); 6. High or very high risk of extensive atherosclerotic diseases; 7. Patients who have had gastrointestinal bariatric surgery in the past year or who have taken weight-loss drugs in the past three months have lost more than 10% of their body weight; 8. Drug or narcotic drug abuse history; 9. Pregnant and lactating women and cardiovascular, lung, kidney, hematopoietic system and other major primary diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal genome sequencing;Genome sequencing of tongue coating samples;Liver function;Blood fat;Fasting blood-glucose;Liver, bile, pancreas and spleen ultrasound;Body Mass Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 Quality of Life Questionnaire;Information collection of TCM physique scale; | — |
Countries
China
Contacts
Wuxi Second People's Hospital