The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Obesity: A Prospective, Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- the Percentage of weight loss
研究概览
简要总结
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.
详细描述
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
the Percentage of weight loss
时间窗: 1 year
次要结局
- 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.)
- Postprandial 2-hour blood glucose(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- HbA1c(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Total cholesterol(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Low-Density Lipoprotein(LDL)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- High-Density Lipoprotein(HDL)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Triglycerides(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Alanine Aminotransferase(ALT)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Aspartate Aminotransferase(AST)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- uric acid(UA)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Blood pressure(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- 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.)
研究者
Hua Meng
Department of General Surgery & Obesity and Metabolic Disease Center
China-Japan Friendship Hospital