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Endothelial Dysfunction in Obese Children (EDOC)

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ClinicalTrials.gov Identifier: NCT01461226
Recruitment Status : Unknown
Verified October 2011 by Conraads Viviane, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : October 28, 2011
Last Update Posted : October 31, 2011
Sponsor:
Collaborator:
Zeepreventorium
Information provided by (Responsible Party):
Conraads Viviane, University Hospital, Antwerp

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.

Condition or disease Intervention/treatment Phase
Obesity Atherosclerosis Behavioral: Exercise training Behavioral: Usual care Phase 3

Detailed Description:

The favorable responses of combined treatment strategies, consisting of exercise training and proper diet change, for childhood and adolescent obesity on vascular health are poorly understood. The overall objective of this research project is to investigate the underlying pathophysiological mechanisms that mediate these beneficial effects.

Particularly, the following aims are set forth:

  1. To establish the effect of a combined lifestyle intervention, i.e. an individualized exercise training and caloric restriction program, on vascular function (primary endpoint) and structure in a substantial population of obese adolescents.
  2. To characterize causal pathways between obesity and endothelial dysfunction with focus on classical risk factors, oxidative and inflammatory stress, metabolic adaptations, bone marrow derived progenitor cells, and blood microparticles.

This research knowledge will be instrumental for risk stratification and clinical management aimed to improve endothelial function by limiting damage and reinforcing regenerative mechanisms in obese adolescents.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?
Study Start Date : June 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Exercise training Behavioral: Exercise training
Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
Usual Care Behavioral: Usual care
Nutritional assessment and dietary advice by general practitioner, promotion of sports activities


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Reactive Hyperemia Index at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ]
    Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function


Secondary Outcome Measures :
  1. Change from baseline in exercise capacity at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ]
    Exercise capacity will be assessed using bicycle ergometry

  2. Change from baseline in Body Mass Index and body composition at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ]
    Weight and Length will be assessed to calculate Body Mass Index(BMI) and BMI-Z-score. Dual-X-Ray Absorptiometry will be used to estimate body composition


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Children with severe obesity

  • Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
  • Older than 16 yrs: BMI ≥35 kg/m²

Exclusion Criteria:

  • Acute or chronic inflammatory process, use of non-steroidal anti- inflammatory drugs or immunosuppressive drugs. (including inhalation corticosteroids).
  • Structural heart disease or other cardiac diseases.
  • Active malignant hematological disease
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461226


Contacts
Contact: Viviane M Conraads, M.D., PhD 38215672 ext 0032 viviane.conraads@uza.be
Contact: Luc Bruyndonckx, M.D. 38215222 ext 0032 luc.bruyndonckx@uza.be

Locations
Belgium
Zeepreventorium Recruiting
De Haan, Belgium, 8420
Contact: Hilde Franckx, M.D.    59233911 ext 0032    hilde.franckx@zeepreventorium.be   
Principal Investigator: Hilde Franckx, M.D.         
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Viviane M Conraads, M.D.,PhD    38214672 ext 0032    viviane.conraads@uza.be   
Sub-Investigator: Luc Bruyndonckx, M.D.         
Dienst Pediatrie, Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: José Ramet, M.D, PhD    38214115 ext 0032    jose.ramet@uza.be   
Principal Investigator: José Ramet, M.D., PhD         
Sub-Investigator: Luc Bruyndonckx, M.D.         
Sponsors and Collaborators
University Hospital, Antwerp
Zeepreventorium
Investigators
Principal Investigator: Viviane M Conraads, M.D., PhD Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Conraads Viviane, Principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01461226     History of Changes
Other Study ID Numbers: EC 11/11/100
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011

Keywords provided by Conraads Viviane, University Hospital, Antwerp:
overweight
cardiovascular risk factors
exercise training
 endothelial function
endothelium
endothelial progenitor cells

Additional relevant MeSH terms:
Obesity
Atherosclerosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases