Endothelial Dysfunction in Obese Children

University Hospital, Antwerp61 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Atherosclerosis

Interventions

Exercise trainingBEHAVIORAL

Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance

Usual careBEHAVIORAL

Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Zeepreventorium

De Haan, Belgium

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Dienst Pediatrie, Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Outcomes

Primary Outcomes

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

Time frame: Baseline - 5 months - 10 months

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline - 5 months - 10 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.