Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
Recruiting · NCT03635541 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
observational group of NAFLD
What this trial is about
It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 500. Liver biopsy proved NAFLD patients will be recruited in this study for 10 years follow-up. Patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 1\. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written informed consent.
Exclusion criteria
- 1\. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.
- \. Patients undergone bariatric surgery. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:
- Hepatocellular carcinoma or suspected liver cancer,
- Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- Other malignancy,
- Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.
Where it is running
1 location listed.
- Beijing Friendship Hospital, Capital Medical University - Beijing, Beijing Municipality, China