NCT01461226

Endothelial Dysfunction in Obese Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Atherosclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Exercise training	Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
BEHAVIORAL	Usual care	Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2011-10-28
• Last updated: 2023-05-15
• Results posted: 2023-05-15

Locations

3 sites across 1 country: Belgium