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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Central Blood Pressure, Subclinical Organ Damage, Children, Adolescent

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark | Behavioral: Lifestyle intervention<br>* Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark<br>|
| No Intervention: Control<br>Healthy age and gender matched control subjects. Recruited from school visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Blood Pressure | Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia. | one year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave velocity | Measured in meters per second. | one year follow up | 
| Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure | 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. | one year follow up | 
| Heart Rate variability |  | one year follow up | 
| Metabolic and Cardiovascular Blood Samples |  | one year follow up | 
| Urine Albumine-Creatinine Ratio (UACR) | 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. | one year follow up | 
| Echocardiography and ultrasound of aortic wall distensibility |  | one year follow up | 
| Electrocardiography | 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. | one year follow up | 
| Dual energy X-ray absorptionmetry (DEXA scan) | 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. | one year follow up | 
| Anthropometric measures | Height, Waist, Weight, BMI (weight/height²) | one year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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