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

This study is currently recruiting participants.
Verified March 2011 by Roskilde County Hospital
Sponsor:
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT01310088
First received: February 28, 2011
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Central Blood Pressure
Obesity
Subclinical Organ Damage
Children
Adolescent
 Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • Central Blood Pressure [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
    Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.


Secondary Outcome Measures:
  • Pulse Wave velocity [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
    Measured in meters per second.

  • Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure [ Time Frame: one year follow up ] [ Designated as safety issue: No ]

    Measured in milimeters of mercury (mm Hg). Analysed into Blood Pressure standard deviation scores (BP SDS).

    Ambulatory Blood Pressure Monitoring (ABPM) is analysed into Amulatory Arterial Stiffness Index (AASI). ASSI is 1 minus the correlation coefficient when the Systolic Blood Pressure is plottet agiant the diastolic Blood Pressure from a ABPM.


  • Heart Rate variability [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
  • Metabolic and Cardiovascular Blood Samples [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
  • Urine Albumine-Creatinine Ratio (UACR) [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
    Microalbuminuria (MAU) defined by urine albumine-creatinine ratio (UACR) ≥ 3,5 mg/mmol (women) and 2,5 mg/mmol (men). Mean of two morning spot urine samples.

  • Echocardiography and ultrasound of aortic wall distensibility [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
  • Electrocardiography [ Time Frame: one year follow up ] [ Designated as safety issue: No ]

    Conventional 12 lead electrocardiography (ECG). Analysis of:

    • Heart rate (beats per minute)
    • P waves, QRS waves, ST segment and T waves (durations: miliseconds, amplitude: milimeters/Voltage)
    • Intervals: PQ, PR, QRS, ST, T waves (miliseconds)
    • Configuration of the T wave.

  • Dual energy X-ray absorptionmetry (DEXA scan) [ Time Frame: one year follow up ] [ Designated as safety issue: No ]

    A full body DEXA scan gives precise knowlegde of the body fat mass and fat free mass. Fat mass can be converted into fat mass index and fat free mass can be converted into fat free mass index, besides BMI standard deviation score (BMI SDS).

    A DEXA scan also gives information on bone mineral density (BMD), a parameter of bone status, and regional estimates: truncus, abdomen, thorax, arms and legs.


  • Anthropometric measures [ Time Frame: one year follow up ] [ Designated as safety issue: No ]
    Height, Waist, Weight, BMI (weight/height²)


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
 Behavioral: Lifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
No Intervention: Control
Healthy age and gender matched control subjects. Recruited from school visits.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310088

Contacts
Contact: Kristian Hvidt, MD 0014559484073 krhv@regionsjaelland.dk

Locations
Denmark
The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen Recruiting
Holbaek, Denmark, 4300
Contact: Jens-Christian Holm, PhD, MD     0014559484208     jhom@regionsjaelland.dk    
Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen Recruiting
Holbaek, Denmark, 4300
Contact: Hans Ibsen, DMSc, MD     0014559484512     hib@regionsjaelland.dk    
Contact: Kristian Hvidt, MD     0014559484073     krhv@regionsjaelland.dk    
Sponsors and Collaborators
Roskilde County Hospital
Investigators
Principal Investigator: Kristian Hvidt, MD Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
Study Chair: Hans Ibsen, DMSc, MD Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
Study Director: Jens-Christian Holm, PhD, MD The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
Study Director: Michael Hecht Olsen, DMSc, PhD, MD Division of Cardiology, Department of Medicine, Glostrup Hospital, University of Copenhagen
  More Information

Publications:

Responsible Party: Kristian Hvidt / MD, Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT01310088     History of Changes
Other Study ID Numbers: AORTA-SJ-166
Study First Received: February 28, 2011
Last Updated: March 10, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
Denmark: National Board of Health

Keywords provided by Roskilde County Hospital:
Childhood
Child
adolescent
central blood pressure
ambulatory blood pressure monitoring
ABPM
clinic blood pressure
pulse wave velocity
 PWV
Pulse cave analysis
PWA
heart rate variability
HRV
Echocardiography
Urine microalbuminuria
blood samples

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013