Clinical trial NCT00801645: Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
Official title: Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Cardiovascular disease
Endothelial function
Blood pressure
Exercise
Physical activity
Metabolic syndrome
Children
Pediatric
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2008-12-03
Enrollment: 67
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial function
timeFrame: 0-3-6-24 months
Secondary outcomes:
measure: Body composition
timeFrame: 0-3-6-24 months
measure: Body mass index
timeFrame: 0-3-6-24 months
measure: Cardiorespiratory fitness
timeFrame: 0-3-6-24 months
measure: Physical activity
timeFrame: 0-3-6-24 months
measure: Insulin resistance
timeFrame: 0-3-6-24 months
measure: Blood lipids
timeFrame: 0-3-6-24 months
measure: Biological markers of endothelial function
timeFrame: 0-3-6-24 months
measure: High sensitive C-reactive protein
timeFrame: 0-3-6-24 months
measure: Resting and ambulatory blood pressure
timeFrame: 0-3-6-24 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Department of Child and Adolescent, University Hospital of Geneva
Study officials:
affiliation: Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva
name: Maurice Beghetti, PD
role: STUDY_DIRECTOR
affiliation: Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva
name: Nathalie J Farpour-Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maggio AB, Aggoun Y, Martin XE, Marchand LM, Beghetti M, Farpour-Lambert NJ. Long-term follow-up of cardiovascular risk factors after exercise training in obese children. Int J Pediatr Obes. 2011 Jun;6(2-2):e603-10. doi: 10.3109/17477166.2010.530665. Epub 2010 Dec 10.
citation: Farpour-Lambert NJ, Aggoun Y, Marchand LM, Martin XE, Herrmann FR, Beghetti M. Physical activity reduces systemic blood pressure and improves early markers of atherosclerosis in pre-pubertal obese children. J Am Coll Cardiol. 2009 Dec 15;54(25):2396-406. doi: 10.1016/j.jacc.2009.08.030.