Nonalcoholic Fatty Liver Disease
Conditions
Interventions
Intervention group :Patients who meet the eligibility criteria are treated with oleanolic acid tablets 60mg 3 times daily for 12 weeks on the baisi of lifestyle intervention.
Control group:Patients who meet the eligibility criteria are treated with silymarin 70mg 3 times daily for 12 weeks on the baisi of lifestyle intervention.
Sponsors
The First Affiliated Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. With no history of drinking; or no more than one standard drink/day(i.e. 70g ethanol/week) for women and no more than 2 standard drinks/day (i.e. 140g ethanol/week) for men; 3. Exclude other cause of fatty liver diseases such as viral hepatitis, drug-induced hepatitis, total parenteral nutrition, hepatolenticular degeneration, autoimmune liver disease; 4. Liver imaging findings (ultrasound or MRI-PDFF quantification of intrahepatic fat content >5.6%) meet the diagnostic criteria for fatty liver and have no other reason to explain; 5. Increased transaminase (ALT or AST) (= 3 times the upper limit of normal) or histological changes in liver biopsy in the past 6 months meet the pathological diagnostic criteria for fatty liver disease or NAFLD activity score (NAS) > 4.
Exclusion criteria
Exclusion criteria: 1. With a history of alcoholism, the amount of alcohol intaked by men = 140g per week, and that of women = 70g; 2. Any causes of chronic liver disease other than NAFLD (such as but not restricted to viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, hypothyroidism, infection, and biliary tract disease, etc.); 3. Patients who have taken the following drugs that may affect liver fat content within the last 4 weeks: such as hypoglycemic agents, lipid-lowering drugs (eg,statins, fibrates, etc.), silybin or silymarin, ursodeoxycholic acid, bicyclol, phosphatidylcholine, and vitamin E, Glucocorticoid, ect.; 4. Patients with significantly impaired liver function (transaminase > 3 times upper limit of normal), abnormal renal function (blood creatinine = normal upper limit 2 times); 5. Patients with serum triglyceride = 5.0 mmol/L; 6. Patient with diabetes or a history of bariatric surgery; 7. Patients with a history of clinically significant heart disease (myocardial infarct, heart failure, and or severe cardiac rhythm) or malignant tumor; 8. Patients with gestation or possible gestation or lactation, or males or females who expecting gestation during clinical trial; 9. Mental disease patients; those who refuse to sign informed consent; 10. Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver fat content detected by MRI-proton density fat fraction(PDFF); | — |
Secondary
| Measure | Time frame |
|---|---|
| liver enzymes;Serum Lipid;Index of inflammation;adipokines,;Index of glucose metabolism;PCSK9; | — |
Countries
China
Contacts
Public ContactHongwen Zhou
The First Affiliated Hospital, Nanjing Medical University
Outcome results
None listed