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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03732326
Enrollment
200
Registered
2018-11-06
Start date
2018-10-24
Completion date
2019-10-24
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Cardiac and Vascular Structure and Function

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.

Interventions

PROCEDUREbariatric surgery

Bariatric surgery for enrolled patients who fulfill the including criteria

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
left ventricular mass index1 yearchanges of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year
value of E and A peak1 yearchanges of value of E and A peak representing cardiac diastolic function measured by ultrasound will be seen from baseline at 1 year
EF1 yearchanges of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year
pulse wave velocity1 yearchanges of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year
flow-mediated dilatation1 yearchanges of flow-mediated dilatation representing vascular function measured by UNEX EF will be seen from baseline at 1 year

Countries

China

Contacts

Primary ContactShikai Yu, MD
shikaiyu@yahoo.com+86 18801790211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026