Clinical trial

Bariatric Surgery Combined With GLP-1RA: A Multicenter Study.

Recruiting now · Not applicable · 1 countries · Registry ID NCT07732738

Recruiting nowNot applicableInterventional

What this study is about

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. Given the lack of multi-regional validation in China's diverse population, this multicenter study aims to confirm the real-world effectiveness and generalizability of bariatric surgery plus GLP-1RA across distinct regional cohorts.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion Criteria: 1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG). 2. obesity:BMI ≥27.5 kg/m². 3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria. 4. Age range: 16-70 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 and study arms

BS-GLP1RA group

Combination Product

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.