Obese non-alcoholic fatty liver disease
Conditions
Interventions
experimental group:Placement of endoscopic duodenal-jejunal bypass liner
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-65 years; 2. body mass index (BMI) 27.5 to 42 kg/m2, and diet and/or exercise are not effective for weight loss; 3. Patients diagnosed with non-alcoholic fatty liver disease; 4. ASA class I-II; 5. Patients participate in the study voluntarily and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Body weight loss > 4.5 kg within 12 weeks prior to informed consent; 2. Patients who have used non-steroidal anti-inflammatory drugs and/or corticosteroids in the preceding month; 3. Patients who have taken weight loss medication or other medication known to affect gastrointestinal function in the preceding month; 4. Pancreatic islet beta-cell function is poor, fasting serum C-peptide level and/or the area under the curve (AUC) of C-peptide level during the OGTT is low; 5. Iron deficiency or iron deficiency anemia; 6. Digestive tract malformations, such as gastrointestinal atresia; 7. Patients with a history of gallstones, kidney stones, cholecystitis, and/or liver abscess; 8. The presence of infection; 9. Coagulation dysfunction, patients who have taken anticoagulant drugs such as aspirin in the preceding month; 10. Severe liver and/or kidney dysfunction, blood creatinine>180umol/L; 11. Type 1 diabetes patients; 12. Patients who can not tolerate general anesthesia or surgery; 13. History of drug or alcohol abuse or major psychiatric disorder; 14. Patients who have duodenal bulb ulcer, gastric ulcer or with a history of pancreatitis; 15. Patients who have coronary artery disease or with pulmonary dysfunction; 16. Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP); 17. Patients with potential bleeding or telangiectasia throughout the gastrointestinal tract; 18. Patients with a history of autoimmune diseases, such as systemic lupus erythematosus and scleroderma; 19. Patients with contraindications for endoscopy; 20. Pregnancy or prepared to get pregnant; 21. Patients who are participating in other clinical trials; 22. Any other reasons that the investigators consider inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of liver steatosis;Degree of liver fibrosis;Weight loss related parameters;Insulin resistance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device evaluation;Liver function;Blood glucose related parameters;Blood lipids; | — |
Countries
China
Contacts
Public ContactJi Feng
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed