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临床试验/NCT03732326
NCT03732326Unknown不适用

Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月24日最近更新:
适应症

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

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

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

The chief director of department of cardiology

Shanghai 10th People's Hospital

研究点 (1)

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