Clinical trial NCT03732326: Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
Official title: Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Keywords: Cardiac and Vascular Structure and Function
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with morbid obesity, aged 15-65 years and without other severe diseases such as congestive heart failure, serious pulmonary and renal dysfunction and so forth.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: left ventricular mass index
timeFrame: 1 year
measure: value of E and A peak
timeFrame: 1 year
measure: EF
timeFrame: 1 year
measure: pulse wave velocity
timeFrame: 1 year
measure: flow-mediated dilatation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taegtmeyer H, Leichman JG, Reyes M, Lux TR. Early benefits from weight-loss surgery. J Am Coll Cardiol. 2010 Apr 20;55(16):1754; author reply 1754. doi: 10.1016/j.jacc.2009.11.081. No abstract available.
citation: Rider OJ, Francis JM, Ali MK, Petersen SE, Robinson M, Robson MD, Byrne JP, Clarke K, Neubauer S. Beneficial cardiovascular effects of bariatric surgical and dietary weight loss in obesity. J Am Coll Cardiol. 2009 Aug 18;54(8):718-26. doi: 10.1016/j.jacc.2009.02.086.
citation: Petersen KS, Clifton PM, Lister N, Keogh JB. Effect of weight loss induced by energy restriction on measures of arterial compliance: A systematic review and meta-analysis. Atherosclerosis. 2016 Apr;247:7-20. doi: 10.1016/j.atherosclerosis.2016.01.042. Epub 2016 Jan 29.