Overweight or Obese
Conditions
Interventions
trial group:Gastric Bypass Stent System+lifestyle intervention
control group:lifestyle intervention
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, any gender. 2. Obese or overweight patients who have not responded to diet and exercise (lifestyle intervention), meeting one of the following criteria: a. BMI >=32.5 kg/m²; b. BMI >=27.5 kg/m² with Type 2 Diabetes Mellitus (T2DM), regardless of the effectiveness of medical treatment for T2DM; c. BMI >27.5 and =25.0 kg/m² and <27.5 kg/m² with T2DM, where intensive medical therapy fails to achieve glycemic control targets.
Exclusion criteria
Exclusion criteria: 1. Significant weight loss in the past 3 months, defined as a weight loss >=5%. 2. Known use (for >1 week) of drugs or other substances in the past month that cause weight gain or loss, including weight-loss drugs, systemic glucocorticoid therapy, antipsychotic or antidepressant drugs (including Chinese patent medicines and herbal medicines), etc.; 3. Need to take specific drugs during the study (e.g., levothyroxine) whose absorption might be affected by the Gastric Bypass Stent System. 4. American Society of Anesthesiologists (ASA) Physical Status Classification III or higher. 5. Clearly diagnosed with type 1 diabetes. 6. Essentially lost islet ß-cell function, evidenced by fasting C-peptide = 50% of the lower limit of normal or a flat C-peptide response curve during glucose stimulation. 7. Iron deficiency or iron deficiency anemia. 8. Coagulation dysfunction (prothrombin time [PT] prolonged by >3 seconds), or use of anticoagulant or antiplatelet drugs in the past month. 9. Severe liver or kidney dysfunction, defined as AST/ALT >2.5 times the upper limit of normal, total bilirubin >35 µmol/L, or serum creatinine >180 µmol/L. 10. Coronary heart disease, angina pectoris, New York Heart Association (NYHA) functional class III or higher, or pulmonary dysfunction. 11. Previous history of Endoscopic Retrograde Cholangiopancreatography (ERCP). 12. Duodenal bulb ulcer, gastric ulcer; eosinophilic esophagitis, or history/current pancreatitis. 13. Presence of gallstones (with clinical symptoms or stone diameter >20mm). 14. Suspected potential bleeding or telangiectasia in the stomach, esophagus, or small intestine. 15. Gastrointestinal malformation or tumor, such as gastrointestinal atresia or other conditions leading to failure of device placement. 16. History of intestinal obstruction, cholecystitis, or liver abscess. 17. Previous history of gastrointestinal bariatric surgery or major gastrointestinal surgery, where the investigator deems the patient unsuitable for placement of the Gastric Bypass Stent System. 18. Secondary obesity, such as hypothyroidism, hypothalamic tumor, Cushing's syndrome, hypogonadism, or other genetic syndromes. 19. History of systemic lupus erythematosus or scleroderma. 20. Known active infection, where the type and severity are deemed by the clinician to make the patient unsuitable for enrollment. 21. Contraindications to endoscopy (investigator's judgment); 22. Pregnancy or intention to conceive; 23. Drug/alcohol addiction or uncontrolled mental illness; 24. Known or suspected hypersensitivity to Nickel-Titanium alloy (Nitinol); 25. Ongoing participation in other clinical trials for drugs or medical devices before completing the endpoints; 26. Any other condition deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with weight loss = 5%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with weight loss = 5%;Excess Weight Loss;Total Body Weight Loss;BMI;Waist circumference;Blood pressure;Total Cholesterol, TC;triglyceride, TG;Low density lipoprotein, LDL;High density lipoprotein, HDL;HbA1c;fasting blood glucose, FPG;Fasting Plasma Insulin, FPI;Fasting C-peptide, FC-P; | — |
Countries
China
Contacts
Public ContactJinghai Song
Beijing Hospital
Outcome results
None listed