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临床试验/NCT07633639
NCT07633639招募中不适用

The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1

研究概览

简要总结

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor agonist therapy for Chinese patients with 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. Tirzepatide, as the first approved GLP-1/GIP dual-target agonist, demonstrates superior hypoglycemic and weight loss effects compared to Semaglutide through its synergistic interaction with GLP-1. Mazdutide, the first GLP-1/GCG dual-target agonist to enter phase III clinical trials in China, promotes fatty acid oxidation and energy consumption while acting synergistically with GLP-1's appetite-suppressing effect. It can effectively reduce liver fat content while achieving weight loss.

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. We will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in Chinese patients with 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

盲法说明

The decision to add GLP-1RAs as adjuvant therapy after sleeve gastrectomy, including which specific drug to use, is made by the attending physicians based on each patient's clinical condition. The researchers do not intervene in the treatment assignment for any patient.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).
  • obesity:BMI ≥30 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:
  • 5.1Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR <30 mL/min/1.73m²). 5.2Active malignancy (except non-melanoma skin cancers). 5.3Autoimmune disorders requiring immunosuppression. 5.4Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression).

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua Meng

Prof.

China-Japan Friendship Hospital

研究点 (1)

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