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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Zealand University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310088
First Posted: March 7, 2011
Last Update Posted: March 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zealand University Hospital
February 28, 2011
March 7, 2011
March 11, 2011
March 2011
June 2013   (Final data collection date for primary outcome measure)
Central Blood Pressure [ Time Frame: one year follow up ]
Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.
Same as current
Complete list of historical versions of study NCT01310088 on ClinicalTrials.gov Archive Site
  • Pulse Wave velocity [ Time Frame: one year follow up ]
    Measured in meters per second.
  • Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure [ Time Frame: one year follow up ]

    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 ]
  • Metabolic and Cardiovascular Blood Samples [ Time Frame: one year follow up ]
  • Urine Albumine-Creatinine Ratio (UACR) [ Time Frame: one year follow up ]
    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 ]
  • Electrocardiography [ Time Frame: one year follow up ]

    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 ]

    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 ]
    Height, Waist, Weight, BMI (weight/height²)
Same as current
Not Provided
Not Provided
 
Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction
Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Central Blood Pressure
  • Obesity
  • Subclinical Organ Damage
  • Children
  • Adolescent
Behavioral: Lifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
  • Experimental: Lifestyle counseling
    Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
    Intervention: Behavioral: Lifestyle intervention
  • No Intervention: Control
    Healthy age and gender matched control subjects. Recruited from school visits.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
December 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01310088
AORTA-SJ-166
No
Not Provided
Not Provided
Kristian Hvidt / MD, Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
Zealand University Hospital
Not Provided
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
Zealand University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP