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RECRUITING
NCT07732738
NA

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

Sponsor: China-Japan Friendship Hospital

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Obesity: A Prospective, Multicenter Cohort Study

Key Details

Gender

All

Age Range

16 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-01-01

Completion Date

2027-12-30

Last Updated

2026-07-29

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

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.

PROCEDURE

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.

Locations (7)

Xingtai Ninth Hospital

Xingtai, Hebei, China

Zhengzhou Central Hospita

Zhengzhou, Henan, China

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

Baotou, Inner Mongolia, China

The Second Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

The First People Hospital Of Yunnan Province

Kunming, Yunnan, China

China-Japan Friendship Hospital

Beijing, China