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NCT07732738

Overview

NCT ID: NCT07732738
Lead Sponsor: China-Japan Friendship HospitalOTHER
Official Title: The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Obesity: A Prospective, Multicenter Cohort Study
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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jan 1, 2025Actual
Primary Completion Date: Dec 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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)

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 400Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Yishan HuangContact
bucmyishan@163.com86+18810621201

Similar Studies

Masking Description

Non-randomized assignment: A total of 400 eligible patients enrolled from participating centers were assigned to either the experimental or control group.

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).
Exposure Factor: GLP-1RA was initiated at 1 month or 3 months after surgery.
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.

Participant Group/Arms

BS-GLP1RA groupExperimental

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 groupOther

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

Procedure: BS group

Locations

Xingtai Ninth HospitalRecruiting

Xingtai, Hebei, China

Canghui WuContact

175639863@qq.com86+18003192321

Zhengzhou Central HospitaRecruiting

Zhengzhou, Henan, China

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

Baotou, Inner Mongolia, China

The Second Hospital, Cheeloo College of Medicine, Shandong UniversityRecruiting

Jinan, Shandong, China

Sinopharm Tongmei General HospitalRecruiting

Datong, Shanxi, China

The First People Hospital Of Yunnan ProvinceRecruiting

Kunming, Yunnan, China

China-Japan Friendship HospitalRecruiting

Beijing, China