Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- left ventricular mass index
研究概览
简要总结
This is a prospective cohort study which aims to explore the effect of bariatric surgery on cardiac and vascular structure and function in obesity. Enrolled patients will receive the following examinations before surgery and 3,6,12 month after the bariatric surgery: 24-h central and brachial ambulatory blood pressure monitoring, PWV, echocardiography, vascular endothelial function, hemodynamic including cardiac output and peripheral vascular resistance and so on. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the cardiac and vascular structure and function.
详细描述
The including citeria: 1)15-65 years old; 2) Indication for Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities ) ;3) available for inspection and therapeutic schedule; 4) available for follow up. The excluding cteria: 1)over 65 years old; 2)myocardial infarction, angina pectoris and ischemic stroke during the previous month;3)congestive heart failure class IV based on the New York Heart Association classification; 4) malignancy or any other condition with poor prognosis; 5) serious pulmonary and renal dysfunction; 6) gastric disease; 7) poor compliance 8) incomplete clinical data .After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight, waist circumference, hip circumference and so on; blood routine tests and biochemical tests. Every patient needs to be assessed before surgery and at 3,6,12 month by 24-h central and brachial ambulatory blood pressure, PWV, echocardiography, vascular endothelial function, cardiac output and peripheral vascular resistance. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the vascular structure and function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15-65 years old
- •conformed indication of Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities )
- •available for inspection and therapeutic schedule
- •available for follow up
排除标准
- •over 65 years old
- •myocardial infarction, angina pectoris and ischemic stroke during the previous month
- •congestive heart failure class IV based on the New York Heart Association classification
- •malignancy or any other condition with poor prognosis
- •serious pulmonary and renal dysfunction
- •gastric disease
- •poor compliance
- •incomplete clinical data
结局指标
主要结局
left ventricular mass index
时间窗: 1 year
changes of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year
EF
时间窗: 1 year
changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year
flow-mediated dilatation
时间窗: 1 year
changes of flow-mediated dilatation representing vascular function measured by UNEX EF will be seen from baseline at 1 year
value of E and A peak
时间窗: 1 year
changes of value of E and A peak representing cardiac diastolic function measured by ultrasound will be seen from baseline at 1 year
pulse wave velocity
时间窗: 1 year
changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year
次要结局
未报告次要终点
研究者
Ya-Wei Xu
The chief director of department of cardiology
Shanghai 10th People's Hospital
