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

Obesity Clinical Trial

— AORTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01310088
• Other study ID #: AORTA-SJ-166
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2011
• Last updated: March 10, 2011
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2011
• Source: Roskilde County Hospital
• Contact: Kristian Hvidt, MD
• Phone: 0014559484073
• Email: krhv[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent
• Central Blood Pressure
• Children
• Obesity
• Subclinical Organ Damage
• Weight Loss

Intervention

Behavioral:
• Lifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Vitarelli A, Giordano M, Germanò 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Blood Pressure	Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.	one year follow up	No
Secondary	Pulse Wave velocity	Measured in meters per second.	one year follow up	No
Secondary	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	No
Secondary	Heart Rate variability		one year follow up	No
Secondary	Metabolic and Cardiovascular Blood Samples		one year follow up	No
Secondary	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	No
Secondary	Echocardiography and ultrasound of aortic wall distensibility		one year follow up	No
Secondary	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	No
Secondary	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	No
Secondary	Anthropometric measures	Height, Waist, Weight, BMI (weight/height²)	one year follow up	No