Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

ConditionObesity

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorChina-Japan Friendship Hospital

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)

obesity:BMI ≥35 kg/m²

Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria

Age range: 18-60 years (inclusive)

Disqualifiers

Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively

Prior bariatric surgery: History of any metabolic/bariatric surgical procedure

Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak)

Non-indicated candidates: Patients not meeting standard bariatric surgery indications

Trial design

Design model

Parallel

Treatments tested in this trial

BS-GLP 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.
BS group
Procedure/Surgery
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: BS-GLP groupExperimental treatment 1 intervention

Group B: BS groupOther 1 intervention

Trial outcomes

Primary outcomes

the Percentage of weight loss

Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.

Time frame

1 year