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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Atherosclerosis | Behavioral: Exercise training Behavioral: Usual care | Phase 3 |
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:
- 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.
- 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 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 |
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
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Usual Care |
Behavioral: Usual care
Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
|
- 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
- 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
- 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

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

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
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 |
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. |
Principal Investigator: | Viviane M Conraads, M.D., PhD | Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen |
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 |