Nonalcoholic steatohepatitis
Conditions
Interventions
nonalcoholic steatohepatitis:None
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily signed a written informed consent form, which is for males or females aged = 18 years old; 2. The subjects are able to communicate well with the researchers and complete the experiment according to the protocol requirements; 3. MRI-PDFF = 10% during screening or within 12 weeks before liver biopsy; 4. All subjects must complete Fibroscan measurements with liver stiffness value (LSM) indicators. During the screening process, suitable probes for the subjects must be used for fiber scanning; During the screening period, 15 kPa>liver hardness value (LSM)>6 kPa measured by instantaneous elastography; 5. When screening, serum ALT>1.0 x ULN; 6. MELD score = 12 points (unless the subject is using anticoagulants); 7. For subjects who receive the following combination medications: It is not allowed to change the dosage within the specified time before liver biopsy (temporary discontinuation or changes in drug category with minimal clinical impact are allowed): a. Glucagon like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium glucose cotransporter-2 inhibitors (SGLT2 inhibitors) or other hypoglycemic drugs: at least 3 months; b. Vitamin E (if dose = 400 IU/day): at least 6 months; c. Statins: at least 3 months; d. Antihypertensive drugs, antidepressants, cardiovascular drugs, and anti hyperlipidemic drugs: at least 3 months;
Exclusion criteria
Exclusion criteria: 1. Those who have merged with other acute or chronic diseases and have been determined by the researcher to be unsuitable for continuing to participate in this trial; 2. Recorded causes of chronic liver disease other than NASH, including but not limited to: a) Recorded as viral hepatitis with i. Hepatitis B surface antigen (HBsAg) positive Ii. Hepatitis C virus ribonucleic acid (RNA) positivity (tested if HCV seropositivity is known at the time of cure or screening). If a subject with a history of HCV infection is HCV PCR negative for more than 3 years, they can be included. b) Drug induced liver damage c) Alcoholic liver disease d) Autoimmune hepatitis e) Wilson's disease f) Hemochromatosis g) Primary biliary cholangitis h) Primary sclerosing cholangitis i) a- 1. Antitrypsin deficiency j) Chronic portal vein thrombosis or splenic vein thrombosis 3. Have a history of liver cirrhosis or evidence of liver cirrhosis, and suspect liver cirrhosis based on clinical biochemical and imaging criteria evaluated by the researcher; 4. Previous or current diagnosis of hepatocellular carcinoma (HCC); 5. History of liver transplantation or planned liver transplantation; Diabetes other than type 6.2 diabetes (for example, type 1, endocrine disease and genetic syndrome); 7. Human Immunodeficiency Virus (HIV) seropositivity; 8. ALT or AST>5 × ULN; 9. A current or recent significant drinking history (<5 years) is usually defined as a male exceeding 30 grams of pure alcohol per day and a female exceeding 20 grams of pure alcohol per day. I didn't drink excessively last year. Consume 75 g of pure alcohol (male) or 60 g of pure alcohol (female) or more within approximately 2 hours;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver biopsy score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological screening;Blood routine indicators;Routine urine parameters;Blood biochemical parameters;Coagulation function indicators;glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactNiu Junqi
The First Hospital of Jilin University
Outcome results
None listed