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

Not Applicable

• Conditions: Central Blood Pressure; Obesity; Subclinical Organ Damage; Children; Adolescent
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT01310088
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-28
• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-07
• Last Update Submitted: 2011-03-10
• Last Update Posted: 2011-03-11
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle intervention	Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark

Primary Outcome Measures

Name	Time	Method
Central Blood Pressure	one year follow up	Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.

Secondary Outcome Measures

Name	Time	Method
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
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.
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	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)	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	one year follow up	Height, Waist, Weight, BMI (weight/height²)

Trial Locations

Locations (2)

Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen; 🇩🇰 Holbaek, Denmark

The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen; 🇩🇰 Holbaek, Denmark