Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

Официальное название

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

Обзор

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.

Подробное описание

"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."

Вмешательства

• Комбинированный продукт BS-GLP 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 s
• Процедура 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.

Первичные конечные точки

• the Percentage of weight loss [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Gender [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Ethnicity [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Height in meters [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Weight in kilograms [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Waist circumference in centimeters [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Hip circumference in centimeters [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Blood pressure [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Serum creatinine [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Glomerular filtration rate [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Fasting blood glucose [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Average blood glucose from continuous glucose monitoring [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Postprandial 2-hour blood glucose [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07336862 · 2023-KY-339

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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