NCT03732326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2019

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 1, 2018

Last Update Submit

November 4, 2018

Conditions

Bariatric Surgery

Keywords

Cardiac and Vascular Structure and Function

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • EF

    changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year

    1 year

  • pulse wave velocity

    changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year

    1 year

  • 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

Interventions

bariatric surgeryPROCEDURE

Bariatric surgery for enrolled patients who fulfill the including criteria

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20394883RESULT

  • 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.

    PMID: 19679250RESULT

  • 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.

    PMID: 26854971RESULT

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Yawei Xu, MD, PhD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shikai Yu, MD

CONTACT

+86 18801790211shikaiyu@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The chief director of department of cardiology

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 6, 2018

Study Start

October 24, 2018

Primary Completion

January 24, 2019

Study Completion

October 24, 2019

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)