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Central Blood PressureAORTANCT01310088

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

A study testing Lifestyle intervention in people with Central Blood Pressure and Obesity, run by Zealand University Hospital at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 18 yearsHealthy volunteers can take part
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesDenmark
Study dates
Mar 2011to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Kristian Hvidt, MD contact

0014559484073

krhv@regionsjaelland.dk

Denmark2 sites, 2 recruiting

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

    Holbæk, 4300

    Hans Ibsen, DMSc, MD, 0014559484512, hib@regionsjaelland.dk

    Kristian Hvidt, MD, 0014559484073, krhv@regionsjaelland.dk

    Recruiting

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

    Holbæk, 4300

    Jens-Christian Holm, PhD, MD, 0014559484208, jhom@regionsjaelland.dk

    Recruiting

Other trials in Denmark

About this study

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.

Being tested
Lifestyle intervention
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
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

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

Study groups in NCT01310088
Study groupRoleWhat they receive
Lifestyle counselingExperimentalTreatment protocol The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Receives: Behavioral: Lifestyle intervention
ControlNo interventionHealthy age and gender matched control subjects. Recruited from school visits.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Blood Pressure

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

    Measured: one year follow up

Secondary outcomes (9)

  1. Pulse Wave velocity

    Measured in meters per second.

    Measured: one year follow up

  2. 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.

    Measured: one year follow up

  3. Heart Rate variability

    Measured: one year follow up

  4. Metabolic and Cardiovascular Blood Samples

    Measured: one year follow up

  5. 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.

    Measured: one year follow up

  6. Echocardiography and ultrasound of aortic wall distensibility

    Measured: one year follow up

  7. 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.

    Measured: one year follow up

  8. 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.

    Measured: one year follow up

  9. Anthropometric measures

    Height, Waist, Weight, BMI (weight/height²)

    Measured: one year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310088
Sponsor's protocol ID
AORTA-SJ-166
Acronym
AORTA
Status last verified
Mar 2011
First submitted
28 Feb 2011
Last updated
11 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20451244

  • 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.

    PubMed 18331423

  • 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.

    PubMed 17885534

  • 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.

    PubMed 16500508

  • 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.

    PubMed 20409984

  • 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.

    PubMed 14688804

  • 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.

    PubMed 16461839

  • 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.

    PubMed 20643663

  • 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.

    PubMed 26726900

  • 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.

    PubMed 24717420

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Central Blood Pressure and Obesity, run by Zealand University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kristian Hvidt, MD (0014559484073, krhv@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Blood Pressure (time frame: one year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01310088, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2011.

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