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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with single therapies. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration require attention. GLP-1 RAs offer distinct advantages for weight and metabolic improvement, and their combined application with surgery may yield synergistic benefits. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG) 2. obesity:BMI ≥35 kg/m² 3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria 4. Age range: 18-60 years (inclusive) 5. willing to sign a consent form: Willing participation with documented consent Who Should NOT Join This Trial: 1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively 2. Prior bariatric surgery: History of any metabolic/bariatric surgical procedure 3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak) 4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications 5. Significant comorbidities: - Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR \<30 mL/min/1.73m²) - Active malignancy (except non-melanoma skin cancers) - Autoimmune disorders requiring immunosuppression - Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG) 2. obesity:BMI ≥35 kg/m² 3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria 4. Age range: 18-60 years (inclusive) 5. Informed consent: Willing participation with documented consent Exclusion Criteria: 1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively 2. Prior bariatric surgery: History of any metabolic/bariatric surgical procedure 3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak) 4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications 5. Significant comorbidities: * Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR \<30 mL/min/1.73m²) * Active malignancy (except non-melanoma skin cancers) * Autoimmune disorders requiring immunosuppression * Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression)

Treatments Being Tested

COMBINATION_PRODUCT

BS-GLP group

1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the intervention group received subcutaneous semaglutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, semaglutide treatment was initiated at 1 month after LSG. The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week. The treatment continued until the completion of the 6-month postoperative period.

PROCEDURE

BS group

1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. Observation Group: Received only basic nutritional recommendation interventions after surgery.

Locations (1)

China-Japan Friendship Hospital
Beijing, China