NCT01310088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

2.3 years

First QC Date

February 28, 2011

Last Update Submit

March 10, 2011

Conditions

Central Blood PressureObesitySubclinical Organ DamageChildrenAdolescent

Keywords

ChildhoodChildadolescentcentral blood pressureambulatory blood pressure monitoringABPMclinic blood pressurepulse wave velocityPWVPulse cave analysisPWAheart rate variabilityHRVEchocardiographyUrine microalbuminuriablood samples

Outcome Measures

Primary Outcomes (1)

  • Central Blood Pressure

    Obtained by the SphygmoCor Device, software version 9, AtCor Medical, Australia.

    one year follow up

Secondary Outcomes (9)

  • Pulse Wave velocity

    one year follow up

  • Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure

    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)

    one year follow up

  • +4 more secondary outcomes

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Treatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

Healthy age and gender matched control subjects. Recruited from school visits.

Interventions

Lifestyle interventionBEHAVIORAL

Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark

Lifestyle counseling

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • children who can not cooperate to DEXA scanning or other procedures
  • linguistic difficulties that impair communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Cardiology, Department of Medicine, Holbaek Hospital, University of Copenhagen

Holbæk, 4300, Denmark

RECRUITING

The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen

Holbæk, 4300, Denmark

RECRUITING

Related Publications (10)

  • 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.

    PMID: 20451244BACKGROUND

  • 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.

    PMID: 18331423BACKGROUND

  • 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.

    PMID: 17885534BACKGROUND

  • 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.

    PMID: 16500508BACKGROUND

  • 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.

    PMID: 20409984BACKGROUND

  • 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.

    PMID: 14688804BACKGROUND

  • 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.

    PMID: 16461839BACKGROUND

  • 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.

    PMID: 20643663BACKGROUND

  • 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.

    PMID: 26726900DERIVED

  • 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.

    PMID: 24717420DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

  • 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

Central Study Contacts

Kristian Hvidt, MD

CONTACT

0014559484073krhv@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations

DK(2)