The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 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. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.
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.
Given the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. The investigators will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in patients with severe obesity."
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（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 ≥35 kg/m²
- •Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria
- •Age range: 18-60 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)
研究组 & 干预措施
BS-GLP group
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.
干预措施: BS-GLP group (Combination Product)
BS group
Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery.
干预措施: BS group (Procedure)
结局指标
主要结局
the Percentage of weight loss
时间窗: 1 year
Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.
次要结局
- Height in meters(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Hip circumference in centimeters(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Gender(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Ethnicity(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.)
- 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.)
- Blood pressure(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Serum creatinine(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Urinary microalbumin and other Urinalysis indexes(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Muscle mass in kilograms(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Visceral fat area(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- Body fat percentage(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.)
- 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.)
- Average blood glucose from continuous glucose monitoring(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.)
- 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.)
- body fat percentage(BFP)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- lean body mass (LBM)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- lean body mass percentage (LBMP)(Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.)
- urine microalbumin-to-creatinine ratio (ACR)(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.)
研究者
Hua Meng
Prof.
China-Japan Friendship Hospital