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

Official title

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

Overview

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.

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.

Previous single-center studies have confirmed the efficacy of this combination therapy. However, given China's vast geographic and ethnic diversity, it remains unclear whether these findings are generalizable to broader populations. This multicenter study is therefore designed to assess the real-world effectiveness and generalizability of bariatric surgery plus GLP-1RA across distinct regional cohorts in China.

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 sem
• 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.

Primary outcome measures

• the Percentage of weight loss [Time frame: 1 year]

Secondary outcome measures (12)

• Weight in kilograms [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Waist circumference in centimeters [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Serum creatinine [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Glomerular filtration rate [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Fasting blood glucose [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Postprandial 2-hour blood glucose [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• HbA1c [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Total cholesterol [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Low-Density Lipoprotein(LDL) [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• High-Density Lipoprotein(HDL) [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Triglycerides [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Alanine Aminotransferase(ALT) [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 7 centers

• Xingtai Ninth Hospital — Xingtai
• Zhengzhou Central Hospita — Zhengzhou
• The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Sci — Baotou
• The Second Hospital, Cheeloo College of Medicine, Shandong University — Jinan
• Sinopharm Tongmei General Hospital — Datong
• The First People Hospital Of Yunnan Province — Kunming
• China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07732738 · BS-GLP-Multic-CN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗