Endothelial Dysfunction in Obese Children (EDOC)

This study is currently recruiting participants.

Verified October 2011 by University Hospital, Antwerp

Sponsor:

Collaborator:

Zeepreventorium

Information provided by (Responsible Party):

Conraads Viviane, University Hospital, Antwerp

ClinicalTrials.gov Identifier:

NCT01461226

First received: October 24, 2011

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

October 28, 2011

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in Reactive Hyperemia Index at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ] [ Designated as safety issue: No ]

Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01461226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in exercise capacity at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ] [ Designated as safety issue: No ]
Exercise capacity will be assessed using bicycle ergometry
Change from baseline in Body Mass Index and body composition at 5 and 10 months [ Time Frame: Baseline - 5 months - 10 months ] [ Designated as safety issue: No ]
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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endothelial Dysfunction in Obese Children

Official Title ^ICMJE

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

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:

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Obesity
Atherosclerosis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Exercise training
Intervention: Behavioral: Exercise training
Usual Care
Intervention: Behavioral: Usual care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01461226

Other Study ID Numbers ^ICMJE

EC 11/11/100

Has Data Monitoring Committee

Responsible Party

Conraads Viviane, University Hospital, Antwerp

Study Sponsor ^ICMJE

University Hospital, Antwerp

Collaborators ^ICMJE

Zeepreventorium

Investigators ^ICMJE

Principal Investigator:

Viviane M Conraads, M.D., PhD

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Information Provided By

University Hospital, Antwerp

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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