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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Experimental | Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark |
|
| Control | No Intervention | Healthy age and gender matched control subjects. Recruited from school visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Blood Pressure | Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia. | one year follow up |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian Hvidt, MD | Contact | 0014559484073 | krhv@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kristian Hvidt, MD | Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark | Principal Investigator |
| Hans Ibsen, DMSc, MD | Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen | Recruiting | Holbæk | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20451244 | Background | 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. | |
| 18331423 | Background | 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. |
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| 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:
| 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 |
| 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 | Study Director |
| The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen | Recruiting | Holbæk | 4300 | Denmark |
|
| 17885534 | Background | 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. |
| 16500508 | Background | 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. |
| 20409984 | Background | 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. |
| 14688804 | Background | 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. |
| 16461839 | Background | 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. |
| 20643663 | Background | 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. |
| 26726900 | Derived | 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. |
| 24717420 | Derived | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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