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

NCT ID: NCT03732326

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-24

Study Completion Date

2019-10-24

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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bariatric surgery

Bariatric surgery for enrolled patients who fulfill the including criteria

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

The chief director of department of cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yawei Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai Tenth People's Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shikai Yu, MD

Role: CONTACT

+86 18801790211

Facility Contacts

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Shikai Yu

Role: primary

+86 18801790211

References

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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.

Reference Type RESULT
PMID: 20394883 (View on PubMed)

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.

Reference Type RESULT
PMID: 19679250 (View on PubMed)

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.

Reference Type RESULT
PMID: 26854971 (View on PubMed)

Other Identifiers

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B-VAS

Identifier Type: -

Identifier Source: org_study_id

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