Nonalcoholic fatty liver disease
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Adult male and female aged 18 to 60 years old. (2) The clinical diagnosis was non-alcoholic steatohepatitis according to pathological results or laboratory test scores within 6 months, elastic ultrasound, etc.; (3) BMI=25kg/m2; (4) Patients understand the purpose of the trial, voluntarily participate in the trial and sign informed consent, and are able and willing to comply with all requirements, including their follow-up and evaluation.
Exclusion criteria
Exclusion criteria: (1) History of excessive alcohol consumption (alcohol equivalent amount > 20 g/d for men and > 10 g/d for women); (2) End-stage liver disease (such as cirrhosis or liver cancer) and other specific conditions that can cause fatty liver disease; (3) Can not cooperate with the completion of magnetic resonance examination; (4) The use of non-steroid anti-inflammatory drugs, corticosteroids in the past month; (5) Patients with iron deficiency or iron deficiency anemia; (6) ALT or AST increased more than 8 times the upper limit of normal, bilirubin increased more than 2 times the upper limit of normal; (7) Patients with coagulation dysfunction or bleeding tendency (platelets <100×109/L); (8) Duodenal bulbar ulcer or past or existing pancreatitis; (9) Patients with a history of liver abscess; (10) Gallstones (with clinical symptoms or stone diameter greater than 20mm); (11) Patients with gastrointestinal bleeding or potential bleeding; (12) Digestive tract malformations, such as patients with digestive tract atresia or other patients that cause digestive tract placement failure; (13) Patients with intestinal obstruction or related history in the past year; (14) Those who abuse drugs or suffer from difficult mental illness; (15) There were contraindications in endoscopy (as judged by the researcher); (16) Pregnant or lactating women; (17) Those who are participating in clinical trials of other drugs or medical devices; (18) Any other patient whom the investigator deems inappropriate to participate in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver puncture histological NAS score and liver tissue fibrosis score;Evaluation on the usability of the device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnetic resonance imaging proton density fat fraction(MRI-PDFF);liver stiffness measurement(LSM);Indicators of liver inflammation/injury(Amino Alanine Transferase(ATL),aspartate aminotransferase(AST),?-glutamyl transferase(GGT),Association of Learning Providers(ALP),Total bilirubin(TBil),Direct Bilirubin(DBil));Blood glucose related index(fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR]);Lipid-related index(triglyceride, total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, and lipoprotein (a));Liver fibrosis related indicators(Forns index, Fibrosis 4, NAFLD FibrosisNFS, S index, Aspartate aminotransferase to platelet ratio index(APRI));Magnetic Resonance Elastography(MRE);total weight loss(TWL),Body Mass Index(BMI);Histological changes; | — |
Countries
China
Contacts
Public ContactGuoliang Ye
The First Affiliated Hospital of Ningbo University
Outcome results
None listed