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Clinical Trials in China / NCT07732738
Recruiting Not applicable

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

NCT07732738 · tracked via the Priya Life Science China tracker
Sponsor
China-Japan Friendship Hospital
Phase
Not applicable
Started
2025-01-01
Last updated
2026-07-29

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

BS-GLP1RA groupBS group

BS-GLP1RA 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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
70 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Xingtai Ninth Hospital Xingtai Hebei Recruiting
Zhengzhou Central Hospita Zhengzhou Henan Recruiting
The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology Baotou Inner Mongolia Recruiting
The Second Hospital, Cheeloo College of Medicine, Shandong University Jinan Shandong Recruiting
Sinopharm Tongmei General Hospital Datong Shanxi Recruiting
The First People Hospital Of Yunnan Province Kunming Yunnan Recruiting
China-Japan Friendship Hospital Beijing China Recruiting

More China-Japan Friendship Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732738 on ClinicalTrials.gov ↗ ← All trials in China