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Completed

NCT Number: NCT01461226

Endothelial Dysfunction in Obese Children

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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeepreventorium, De Haan, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  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 outcomes

  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 at baseline and at 5 and 10 Months

  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) at baseline and after 5 and 10 months

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Zeepreventorium

Registry information

Official study title

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

Acronym: EDOC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2011
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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