Clinical trial NCT01461226: Endothelial Dysfunction in Obese Children
Official title: Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Atherosclerosis
Keywords: overweight
cardiovascular risk factors
exercise training
endothelial function
endothelium
endothelial progenitor cells
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Zeepreventorium
First posted: 2011-10-28
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months
timeFrame: Baseline - 5 months - 10 months
Secondary outcomes:
measure: Change From Baseline in Exercise Capacity at 5 and 10 Months
timeFrame: Baseline - 5 months - 10 months
measure: Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months
timeFrame: Baseline - 5 months - 10 months
Other outcomes:
Locations:
city: De Haan
country: Belgium
facility: Zeepreventorium
city: Edegem
country: Belgium
facility: Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
city: Edegem
country: Belgium
facility: Dienst Pediatrie, Universitair Ziekenhuis Antwerpen
Study officials:
affiliation: Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
name: Viviane M Conraads, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: