Endothelial Dysfunction in Obese Children

Not Applicable

Completed

Brief Summary: The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.

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.

Recruitment & Eligibility

Inclusion Criteria

Children with severe obesity

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

Arm && Interventions

Group	Intervention	Description
Exercise training	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	Usual care	Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months	Baseline - 5 months - 10 months	Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Exercise Capacity at 5 and 10 Months	Baseline - 5 months - 10 months	Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months
Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months	Baseline - 5 months - 10 months	Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months

Locations (3): Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
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Edegem, Belgium
Dienst Pediatrie, Universitair Ziekenhuis Antwerpen
🇧🇪
Edegem, Belgium
Zeepreventorium
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De Haan, Belgium