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Completed

NCT Number: NCT00801645

Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children

The main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Child and Adolescent, University Hospital of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

About this study

Introduction: cardiovascular diseases (CVD) are the major contributor to the global burden of non-communicable diseases, one third of all global death being attributed to CVD. Childhood obesity poses a major public health problem and there is increasing evidence that foundation of cardiovascular diseases lays early in life in obese children. There is therefore an urgent need to identify effective prevention strategies. Physical activity is recognized as major determinants of cardiovascular health in adults and adolescents however, little is known in young children. The main purpose of this project is to investigate the effects of a 3-month exercise training program on arterial function and cardiovascular diseases risk factors in obese and lean children.

Methods: This is a randomized controlled trial including 4 groups of pre-pubertal children aged 6 to 11 years old: 1) obese exercise, 2) obese control, 3) lean exercise, and 4) lean control. The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching. Controls are relatively inactive. After the 3-month intervention, the obese control group engages in an identical 12-week exercise program and the obese exercise group is encouraged to continue for a total of 6 months. Primary measures include: 24-hour ambulatory systolic and diastolic blood pressure; endothelial function and mechanical indices of the brachial and carotid arteries using a B-mode ultrasound imager; central blood pressure and pulse wave velocity by tonometry of aplanation. Other measures include: body composition, physical activity, cardio-respiratory fitness, nutrition, quality of life, and fasting blood lipids, insulin, glucose, markers of vascular function and inflammation. Testing is performed at baseline, 3, 6 and 24 months in obese children and at baseline and 3 months in lean children.

We hypothesize that exercise training will result in improved arterial function, body composition and markers of the metabolic syndrome in obese children. This information will be used to underpin prevention strategies to reduce CVD risk factors in this high-risk population.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • obese children: Pre-pubertal (Tanner stage 1), BMI > 97th age- and gender-specific percentile (Kromeyer-Hauschild et al. 2001).
  • lean subjects: Pre-pubertal (Tanner stage 1), BMI > 10th and < 90th age- and gender-specific percentile.

Exclusion criteria

  • being involved in any weight control, physical activity, or behavioral therapy
  • familial history of dyslipidemia or essential hypertension
  • medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism
  • orthopedic affection limiting physical activity
  • genetic disorder or a chronic disease
  • following a therapy for psychiatric problems

Treatment and study plan

Exercise

Behavioral

The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.

Other names: Physical activity

Primary outcomes

  1. Arterial function

    Time frame: 0-3-6-24 months

Secondary outcomes

  1. Body composition

    Time frame: 0-3-6-24 months

  2. Body mass index

    Time frame: 0-3-6-24 months

  3. Cardiorespiratory fitness

    Time frame: 0-3-6-24 months

  4. Physical activity

    Time frame: 0-3-6-24 months

  5. Insulin resistance

    Time frame: 0-3-6-24 months

  6. Blood lipids

    Time frame: 0-3-6-24 months

  7. Biological markers of endothelial function

    Time frame: 0-3-6-24 months

  8. High sensitive C-reactive protein

    Time frame: 0-3-6-24 months

  9. Resting and ambulatory blood pressure

    Time frame: 0-3-6-24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2010
First posted
Dec 3, 2008
Registry last updated
Jan 5, 2012

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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