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

Primary Purpose

Central Blood Pressure, Obesity, Subclinical Organ Damage

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Lifestyle intervention

About this trial

This is an interventional treatment trial for Central Blood Pressure focused on measuring 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

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Division of Cardiology, Department of Medicine, Holbaek Hospital, University of CopenhagenRecruiting
The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Central Blood Pressure

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

Secondary Outcome Measures

Pulse Wave velocity

Measured in meters per second.

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.

Heart Rate variability

Metabolic and Cardiovascular Blood Samples

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.

Echocardiography and ultrasound of aortic wall distensibility

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.

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.

Anthropometric measures

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

Full Information

NCT ID

NCT01310088

First Posted

February 28, 2011

Last Updated

March 10, 2011

Sponsor

Zealand University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01310088

Brief Title

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

Acronym

AORTA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Zealand University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Blood Pressure, Obesity, Subclinical Organ Damage, Children, Adolescent

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle counseling

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Central Blood Pressure

Description

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

Time Frame

one year follow up

Secondary Outcome Measure Information:

Title

Pulse Wave velocity

Description

Measured in meters per second.

Time Frame

one year follow up

Title

Ambulatory Blood Pressure Monitoring and Clinic Blood Pressure

Description

Time Frame

one year follow up

Title

Heart Rate variability

Time Frame

one year follow up

Title

Metabolic and Cardiovascular Blood Samples

Time Frame

one year follow up

Title

Urine Albumine-Creatinine Ratio (UACR)

Description

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.

Time Frame

one year follow up

Title

Echocardiography and ultrasound of aortic wall distensibility

Time Frame

one year follow up

Title

Electrocardiography

Description

Time Frame

one year follow up

Title

Dual energy X-ray absorptionmetry (DEXA scan)

Description

Time Frame

one year follow up

Title

Anthropometric measures

Description

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

Time Frame

one year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristian Hvidt, MD

Phone

0014559484073

krhv@regionsjaelland.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristian Hvidt, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hans Ibsen, DMSc, MD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jens-Christian Holm, PhD, MD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Michael Hecht Olsen, DMSc, PhD, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Holbaek

ZIP/Postal Code

4300

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hans Ibsen, DMSc, MD

Phone

0014559484512

hib@regionsjaelland.dk

First Name & Middle Initial & Last Name & Degree

Kristian Hvidt, MD

Phone

0014559484073

krhv@regionsjaelland.dk

Facility Name

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

City

Holbaek

ZIP/Postal Code

4300

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jens-Christian Holm, PhD, MD

Phone

0014559484208

jhom@regionsjaelland.dk

12. IPD Sharing Statement

Citations:

PubMed Identifier

20451244

Citation

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.

Results Reference

background

PubMed Identifier

18331423

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.

Results Reference

background

PubMed Identifier

17885534

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. doi: 10.1097/HJH.0b013e3282775992.

Results Reference

background

PubMed Identifier

16500508

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. doi: 10.1016/j.amjhyper.2005.09.018.

Results Reference

background

PubMed Identifier

20409984

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.

Results Reference

background

PubMed Identifier

14688804

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. doi: 10.1038/sj.jhh.1001620.

Results Reference

background

PubMed Identifier

16461839

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. doi: 10.1161/CIRCULATIONAHA.105.579342.

Results Reference

background

PubMed Identifier

20643663

Citation

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.

Results Reference

background

PubMed Identifier

26726900

Citation

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.

Results Reference

derived

PubMed Identifier

24717420

Citation

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.

Results Reference

derived

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

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