Bariatric Surgery Combined With GLP-1 Receptor Agonists Study (BS-GLP)

China-Japan Friendship Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obesity

Treatments: Combination Product: BS-GLP group; Procedure: BS group

Study type: Interventional

Funder types: Other

Identifiers

NCT07336862

2023-KY-339

Details and patient eligibility

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. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.

Full description

"bariatric surgery is guideline-recommended as an effective obesity treatment. Substantial evidence demonstrates its ability to significantly reduce weight, improve comorbidities like type 2 diabetes (T2DM) and dyslipidemia, and lower cardiovascular risk. However, the significant heterogeneity and complex comorbidity profiles among obese patients challenge long-term effective management with single therapeutic approaches. While currently the most effective weight-loss intervention, bariatric surgery requires attention to issues such as postoperative weight regain and metabolic deterioration.

In parallel, Glucagon-like peptide-1 receptor agonists (GLP-1RA) have demonstrated significant efficacy in obesity management. Agents like semaglutide promote weight loss and metabolic improvement through mechanisms including insulin secretion promotion, appetite suppression, delayed gastric emptying, and enhanced satiety.

Given the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. The investigators will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in patients with severe obesity."

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

BS-GLP group

Experimental group

Description:

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: Semaglutide. Dosage: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. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.

Treatment:

Combination Product: BS-GLP group

BS group

Other group

Description:

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery.

Treatment:

Procedure: BS group