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

NCT07732738 | Recruiting

• 1 other identifier: BS-GLP-Multic-CN
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 7

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. 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.

Conditions

Obesity

Keywords

obesity; Glucagon-Like Peptide-1 Receptor Agonist; Bariatric Surgery; multicenter

Outcome Measures

Primary Outcomes (1)

• the Percentage of weight loss

  1 year

Secondary Outcomes (15)

• Weight in kilograms

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Waist circumference in centimeters

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Serum creatinine

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Glomerular filtration rate

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Fasting blood glucose

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Other Outcomes (6)

• body fat percentage(BFP)

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Visceral fat area

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

• Muscle mass in kilograms

  Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Study Arms (2)

BS-GLP1RA group

EXPERIMENTAL

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.

Combination Product: BS-GLP1RA group

BS group

OTHER

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

Procedure: BS group

Interventions

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.

BS-GLP1RA group

BS group 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.

BS group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).
• obesity:BMI ≥27.5 kg/m².
• Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria.
• Age range: 16-70 years (inclusive).
• Informed consent: Willing participation with documented consent.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (7)

Xingtai Ninth Hospital

Xingtai, Hebei, China

RECRUITING

Zhengzhou Central Hospita

Zhengzhou, Henan, China

RECRUITING

The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

RECRUITING

The Second Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

RECRUITING

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

RECRUITING

The First People Hospital Of Yunnan Province

Kunming, Yunnan, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yishan Huang

CONTACT

86+18810621201; bucmyishan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Non-randomized assignment: A total of 400 eligible patients enrolled from participating centers were assigned to either the experimental or control 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. Exposure Factor: GLP-1RA was initiated at 1 month or 3 months after surgery. 3. Grouping 3.1Observation Group: Received only basic nutritional recommendation interventions after surgery. 3.2Treatment Group: Initiated GLP-1RA at 1 month or 3 months after surgery. Based on the actual timing of use, patients were further categorized into high-, medium-, and low-exposure subgroups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of General Surgery & Obesity and Metabolic Disease Center

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

CN (7)