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Clinical Trials/NCT01310088
NCT01310088
Unknown
Not Applicable

Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction

Zealand University Hospital2 sites in 1 country100 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Blood Pressure
Sponsor
Zealand University Hospital
Enrollment
100
Locations
2
Primary Endpoint
Central Blood Pressure
Last Updated
15 years ago

Overview

Brief Summary

The global epidemic of obesity in childhood continues to evolve and threaten future health and life expectancy primarily due to the increased incidence of cardiovascular disease. Obesity is strongly related to high blood pressure (hypertension) and both conditions pose a risk for target organ damage, which can follow a subject from childhood into adult life. The AORTA study will investigate central hemodynamics and organ damage in 100 obese children and adolescents in order to gain insight to the complex interplay of hypertension, obesity and subclinical damage in order to intensify more precise prevention, thereby reducing the future development of cardiovascular disease.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2013
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 10-18
  • BMI for age and sex above 95 percentile
  • referred for treatment at the The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
  • oral and written consent by their parents

Exclusion Criteria

  • children who can not cooperate to DEXA scanning or other procedures
  • linguistic difficulties that impair communication

Outcomes

Primary Outcomes

Central Blood Pressure

Time Frame: one year follow up

Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.

Secondary Outcomes

  • Pulse Wave velocity(one year follow up)
  • Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure(one year follow up)
  • Heart Rate variability(one year follow up)
  • Urine Albumine-Creatinine Ratio (UACR)(one year follow up)
  • Echocardiography and ultrasound of aortic wall distensibility(one year follow up)
  • Metabolic and Cardiovascular Blood Samples(one year follow up)
  • Electrocardiography(one year follow up)
  • Dual energy X-ray absorptionmetry (DEXA scan)(one year follow up)
  • Anthropometric measures(one year follow up)

Study Sites (2)

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