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

Официальное название

The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With 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. 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.

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.

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.

Вмешательства

• Комбинированный продукт 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
• 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)

• 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.]
• 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.]
• Postprandial 2-hour blood glucose [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• HbA1c [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Total cholesterol [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Low-Density Lipoprotein(LDL) [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• High-Density Lipoprotein(HDL) [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Triglycerides [Срок оценки: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
• Alanine Aminotransferase(ALT) [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 ≥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.

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 · 7 центров

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

Идентификаторы

NCT: NCT07732738 · BS-GLP-Multic-CN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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