The Influence of Laparascopic SLeeve gAstrectomy Vs. Endoscopic Gastric Plication on Body weIght, Metabolic pArameters and Microbiota Composition in Patients With Obesity: Randomized, Open-labelled Study (SLAVIA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Body Weight
研究概览
简要总结
The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.
详细描述
Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. The aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. A further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. The results of the project will describe the efficacy and safety of these procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •BMI > 35 kg/m2
- •For patients with type 2 diabetes - stable antidiabetic medication > 1 month
- •Age 18-60 years
排除标准
- •Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
- •Prior gastrointestinal (GIT) surgery interfering with study procedure
- •Severe gastroesophageal reflux, severe GIT motility disorder
- •Active malignancy
- •Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
- •Acute liver or kidney failure
- •Transplantation of insulin producing tissue
- •Gravidity or lactation
- •Mental disorder
- •Inability to sign informed consent
- •Any other contraindication of bariatric surgery or bariatric endoscopy procedure
- •Acute liver or kidney failure
- •Transplantation of insulin producing tissue
- •Gravidity or lactation
- •Mental disorder
- •Inability to sign informed consent
- •Any other contraindication of bariatric surgery or bariatric endoscopy procedure
结局指标
主要结局
Change in Body Weight
时间窗: 6 months
To compare the change in body weight after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity
次要结局
- Change in Glycated Hemoglobin(6 months)
- Change in serum glucagon-like peptide 1 (GLP-1)(6 months)
- Change in fasting blood glucose(6 months)
研究者
Julius Spicak
prof. MUDr. Julius Spicak, CSc.
Institute for Clinical and Experimental Medicine