Endothelial Dysfunction in Obese Children (EDOC)

• ClinicalTrials.gov Identifier: NCT01461226
• Recruitment Status: Unknown
• First Posted: October 28, 2011
• Last Update Posted: October 31, 2011
• Sponsor: University Hospital, Antwerp
• Collaborator: Zeepreventorium
• Information provided by (Responsible Party): Conraads Viviane, University Hospital, Antwerp

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:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: June 2011
• Estimated Primary Completion Date: July 2013
• Estimated Study Completion Date: September 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
Usual Care	Behavioral: Usual care; Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in Reactive Hyperemia Index at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ]
   Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Secondary Outcome Measures :

1. Change from baseline in exercise capacity at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ]
   Exercise capacity will be assessed using bicycle ergometry
2. Change from baseline in Body Mass Index and body composition at 5 and 10 months [ Time Frame: 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

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Viviane M Conraads, M.D., PhD; 38215672 ext 0032; viviane.conraads@uza.be

Contact: Luc Bruyndonckx, M.D.; 38215222 ext 0032; luc.bruyndonckx@uza.be

Locations

Belgium

Zeepreventorium; Recruiting

De Haan, Belgium, 8420

Contact: Hilde Franckx, M.D. 59233911 ext 0032 hilde.franckx@zeepreventorium.be

Principal Investigator: Hilde Franckx, M.D.

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen; Recruiting

Edegem, Belgium, 2650

Contact: Viviane M Conraads, M.D.,PhD 38214672 ext 0032 viviane.conraads@uza.be

Sub-Investigator: Luc Bruyndonckx, M.D.

Dienst Pediatrie, Universitair Ziekenhuis Antwerpen; Recruiting

Edegem, Belgium, 2650

Contact: José Ramet, M.D, PhD 38214115 ext 0032 jose.ramet@uza.be

Principal Investigator: José Ramet, M.D., PhD

Sub-Investigator: Luc Bruyndonckx, M.D.

Sponsors and Collaborators

University Hospital, Antwerp

Zeepreventorium

Investigators

• Principal Investigator: Viviane M Conraads, M.D., PhD; Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

More Information

• Responsible Party: Conraads Viviane, Principal Investigator, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT01461226
• Other Study ID Numbers: EC 11/11/100
• First Posted: October 28, 2011
• Last Update Posted: October 31, 2011
• Last Verified: October 2011

Keywords provided by Conraads Viviane, University Hospital, Antwerp:

overweight; cardiovascular risk factors; exercise training; endothelial function; endothelium; endothelial progenitor cells

Additional relevant MeSH terms:

Atherosclerosis; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases