Endothelial Dysfunction in Obese Children

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

Detailed Description
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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.

Official Title
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Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?

Conditions
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Obesity, Atherosclerosis

Intervention / Treatment
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* Behavioral: Exercise training
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, cardiovascular risk factors, exercise training, endothelial function, endothelium, endothelial progenitor cells