EDOC: Endothelial Dysfunction in Obese Children

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Unknown status

CT.gov ID

NCT01461226

Collaborator

Zeepreventorium (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Atherosclerosis	Behavioral: Exercise training Behavioral: Usual care	Phase 3

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Exercise training

Behavioral: Exercise training

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

Other: Usual Care

Behavioral: Usual care

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

Outcome Measures

Primary Outcome Measures

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

Change from baseline in exercise capacity at 5 and 10 months [Baseline - 5 months - 10 months]
Exercise capacity will be assessed using bicycle ergometry
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) and BMI-Z-score. Dual-X-Ray Absorptiometry will be used to estimate body composition

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Zeepreventorium	De Haan	Belgium	8420
2	Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen	Edegem	Belgium	2650
3	Dienst Pediatrie, Universitair Ziekenhuis Antwerpen	Edegem	Belgium	2650