Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

NCT ID: NCT07336862

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed 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."

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BS-GLP group

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.

Group Type: EXPERIMENTAL

BS-GLP group

Intervention Type: 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

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

Group Type: OTHER

BS group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hua Meng

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hua Meng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yishan Huang, Ph.D

Role: CONTACT

bucmyishan@163.com

18810621201

Facility Contacts

Yishan Huang, Ph.D

Role: primary

bucmyishan@163.com

18810621201

Other Identifiers

2023-KY-339

Identifier Type: -

Identifier Source: org_study_id