Clinical trial NCT01310088: Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction
Official title: Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Blood Pressure
Obesity
Subclinical Organ Damage
Children
Adolescent
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
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Central Blood Pressure
timeFrame: one year follow up
Secondary outcomes:
measure: Pulse Wave velocity
timeFrame: one year follow up
measure: Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure
timeFrame: one year follow up
measure: Heart Rate variability
timeFrame: one year follow up
measure: Metabolic and Cardiovascular Blood Samples
timeFrame: one year follow up
measure: Urine Albumine-Creatinine Ratio (UACR)
timeFrame: one year follow up
measure: Echocardiography and ultrasound of aortic wall distensibility
timeFrame: one year follow up
measure: Electrocardiography
timeFrame: one year follow up
measure: Dual energy X-ray absorptionmetry (DEXA scan)
timeFrame: one year follow up
measure: Anthropometric measures
timeFrame: one year follow up
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
city: Holbaek
country: Denmark
facility: The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
Study officials:
affiliation: Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
name: Kristian Hvidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
name: Hans Ibsen, DMSc, MD
role: STUDY_CHAIR
affiliation: The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
name: Jens-Christian Holm, PhD, MD
role: STUDY_DIRECTOR
affiliation: Division of Cardiology, Department of Medicine, Glostrup Hospital, University of Copenhagen
name: Michael Hecht Olsen, DMSc, PhD, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.