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

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732326
• Other study ID #: B-VAS
• Status: Recruiting
• Start date: October 24, 2018
• Est. completion date: October 24, 2019

Study information

• Verified date: November 2018
• Source: Shanghai 10th People's Hospital
• Contact: Shikai Yu, MD
• Phone: +86 18801790211
• Email: shikaiyu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Procedure:
• bariatric surgery
Bariatric surgery for enrolled patients who fulfill the including criteria

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Epu — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular mass index	changes of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year	1 year
Primary	value of E and A peak	changes of value of E and A peak representing cardiac diastolic function measured by ultrasound will be seen from baseline at 1 year	1 year
Primary	EF	changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year	1 year
Primary	pulse wave velocity	changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year	1 year
Primary	flow-mediated dilatation	changes of flow-mediated dilatation representing vascular function measured by UNEX EF will be seen from baseline at 1 year	1 year