Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction
NCT ID: NCT01310088
Last Updated: 2011-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lifestyle counseling
Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Lifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Control
Healthy age and gender matched control subjects. Recruited from school visits.
No interventions assigned to this group
Interventions
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Lifestyle intervention
Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Eligibility Criteria
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Inclusion Criteria
* 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
* linguistic difficulties that impair communication
10 Years
18 Years
ALL
Yes
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
Principal Investigators
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Kristian Hvidt, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen, Denmark
Hans Ibsen, DMSc, MD
Role: STUDY_CHAIR
Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
Jens-Christian Holm, PhD, MD
Role: STUDY_DIRECTOR
The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
Michael Hecht Olsen, DMSc, PhD, MD
Role: STUDY_DIRECTOR
Division of Cardiology, Department of Medicine, Glostrup Hospital, University of Copenhagen
Locations
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Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen
Holbæk, , Denmark
The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
Holbæk, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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AORTA-SJ-166
Identifier Type: -
Identifier Source: org_study_id
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