non-alcoholic fatty liver disease
Conditions
Interventions
Experimental group:Caffeic acid tablet, 0.3g tid po.
Control group:Placebo
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old; 2. BMI 25-35 kg/m2; 3. In the past 20 weeks, the pathological diagnosis of liver biopsy or clinical diagnosis of Nash or NAFLD, or clinical and FibroScan determined (CAP) diagnosis of NAFLD; 4. Patients with abnormal glucose metabolism should meet one of the following conditions: (1) If IGR patients, only lifestyle intervention, no hypoglycemic drugs; (2) Patients with diabetes, who have taken drugs, maintain the original hypoglycemic regimen, but need to stabilize the dose for 2 months or more before randomization; (3) Patients with diabetes, who only received lifestyle intervention, did not need hypoglycemic drugs before randomization; 5. Agree and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Excessive drinking (definition: in the past 6 months, the weekly alcohol intake of men exceeded 140g and that of females exceeded 70g); 2. Liver enzymes (ALT or AST) >=5 ULN; 3. Liver diseases caused by other causes: alcoholic liver disease, acute and chronic viral hepatitis, drug-induced liver disease, autoimmune liver disease, hereditary liver disease, liver cirrhosis, liver cancer, etc; 4. Biliary tract diseases: obstructive diseases of biliary tract, etc; 5. Other diseases affecting glucose and lipid metabolism: hyperthyroidism, hypothyroidism, cortisol excess, etc; 6. HbA1c > 9.5% in patients with poor glycemic control; 7. Drugs that may affect the end point of this study were used within three months before enrollment, including pioglitazone, GLP-1 receptor agonist, ddp-4 inhibitor, insulin and glycyrrhizic acid preparation; 8. For chronic kidney disease or severe renal function impairment, the definition of serum creatinine was greater than (176.8 umol/L); 9. The life expectancy shall not exceed 5 years; 10. Those who are pregnant or plan to become pregnant in the near future within one year; 11. There were other cases that could not complete the intervention follow-up; 12. In the first three months, the patients had taken drugs that might affect steatohepatitis for more than 2 weeks (such as cortisol, methotrexate, etc.); 13. Participated in other clinical trials in recent 4 weeks; 14. The researcher thinks that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled attenuation parameters(CAP); | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function test;Fasting blood glucose;blood lipid;insulin;Human body index (height, weight, waist circumference, hip circumference); | — |
Countries
China
Contacts
Public ContactChen, Yuanwen
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed