Endothelial Dysfunction in Obese Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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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

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Obesity Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise training

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

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

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

Usual Care

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

Group Type OTHER

Usual care

Intervention Type BEHAVIORAL

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

Interventions

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Exercise training

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

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No