Adolescent, Central Blood Pressure, Children, Obesity, Subclinical Organ Damage
Conditions
Keywords
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
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.
Interventions
BEHAVIORALLifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Sponsors
Zealand University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Blood Pressure | one year follow up | Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave velocity | one year follow up | Measured in meters per second. |
| Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure | 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 | one year follow up | — |
| Metabolic and Cardiovascular Blood Samples | one year follow up | — |
| Dual energy X-ray absorptionmetry (DEXA scan) | 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. |
| Echocardiography and ultrasound of aortic wall distensibility | one year follow up | — |
| Electrocardiography | 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. |
| Anthropometric measures | one year follow up | Height, Waist, Weight, BMI (weight/height²) |
| Urine Albumine-Creatinine Ratio (UACR) | 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. |
Countries
Denmark
Contacts
Primary ContactKristian Hvidt, MD
Outcome results
None listed