Endothelial Dysfunction in Obese Children (EDOC)
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Purpose
The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Atherosclerosis |
Behavioral: Exercise training Behavioral: Usual care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible? |
- Change from baseline in Reactive Hyperemia Index at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Conraads Viviane, Principal Investigator, University Hospital, Antwerp |
| ClinicalTrials.gov Identifier: | NCT01461226 History of Changes |
| Other Study ID Numbers: | EC 11/11/100 |
| Study First Received: | October 24, 2011 |
| Last Updated: | October 28, 2011 |
| Health Authority: | Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Antwerp:
|
overweight cardiovascular risk factors exercise training |
endothelial function endothelium endothelial progenitor cells |
Additional relevant MeSH terms:
|
Atherosclerosis Obesity Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013