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

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.

Study Overview

• Status: Unknown
• Conditions: Adolescent; Obesity; Children; Subclinical Organ Damage; Central Blood Pressure
• Intervention / Treatment: Behavioral: Lifestyle intervention

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holbaek, Denmark, 4300
    • Recruiting
    • Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
    • Contact: Kristian Hvidt, MD; Phone Number: 0014559484073; Email: krhv@regionsjaelland.dk
    • Contact: Hans Ibsen, DMSc, MD; Phone Number: 0014559484512; Email: hib@regionsjaelland.dk
  • Holbaek, Denmark, 4300
    • Recruiting
    • The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
    • Contact: Jens-Christian Holm, PhD, MD; Phone Number: 0014559484208; Email: jhom@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zealand University 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

Publications and helpful links

General Publications

• Han JC, Lawlor DA, Kimm SY. Childhood obesity. Lancet. 2010 May 15;375(9727):1737-48. doi: 10.1016/S0140-6736(10)60171-7. Epub 2010 May 5.
• Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5.
• Hvidt KN, Olsen MH, Holm JC, Ibsen H. Obese children and adolescents have elevated nighttime blood pressure independent of insulin resistance and arterial stiffness. Am J Hypertens. 2014 Nov;27(11):1408-15. doi: 10.1093/ajh/hpu055. Epub 2014 Apr 9.
• Stabouli S, Kotsis V, Zakopoulos N. Ambulatory blood pressure monitoring and target organ damage in pediatrics. J Hypertens. 2007 Oct;25(10):1979-86. doi: 10.1097/HJH.0b013e3282775992.
• Hansen TW, Jeppesen J, Rasmussen S, Ibsen H, Torp-Pedersen C. Ambulatory blood pressure monitoring and risk of cardiovascular disease: a population based study. Am J Hypertens. 2006 Mar;19(3):243-50. doi: 10.1016/j.amjhyper.2005.09.018.
• Litwin M, Niemirska A, Ruzicka M, Feber J. White coat hypertension in children: not rare and not benign? J Am Soc Hypertens. 2009 Nov-Dec;3(6):416-23. doi: 10.1016/j.jash.2009.10.002.
• Hansen TW, Jeppesen J, Rasmussen S, Ibsen H, Torp-Pedersen C. Relation between insulin and aortic stiffness: a population-based study. J Hum Hypertens. 2004 Jan;18(1):1-7. doi: 10.1038/sj.jhh.1001620.
• Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.
• Vitarelli A, Giordano M, Germano G, Pergolini M, Cicconetti P, Tomei F, Sancini A, Battaglia D, Dettori O, Capotosto L, De Cicco V, De Maio M, Vitarelli M, Bruno P. Assessment of ascending aorta wall stiffness in hypertensive patients by tissue Doppler imaging and strain Doppler echocardiography. Heart. 2010 Sep;96(18):1469-74. doi: 10.1136/hrt.2010.198358. Epub 2010 Jul 18.
• Muhamed PK, Olsen MH, Holm JC, Ibsen H, Hvidt KN. Cuff size influences blood pressure measurement in obese children and adolescents. Dan Med J. 2016 Jan;63(1):A5183.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 11, 2011
• Last Update Submitted That Met QC Criteria: March 10, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Child; ABPM; ambulatory blood pressure monitoring; adolescent; Childhood; HRV; Echocardiography; pulse wave velocity; heart rate variability; central blood pressure; blood samples; PWV; clinic blood pressure; Pulse cave analysis; PWA; Urine microalbuminuria
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: AORTA-SJ-166