Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
- Conditions
- Bariatric Surgery
- Registration Number
- NCT03732326
- Lead Sponsor
- Shanghai 10th People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method left ventricular mass index 1 year changes of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year
EF 1 year changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year
flow-mediated dilatation 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 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 1 year changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Tenth People's Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China