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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801645
• Other study ID #: SNF 3200B0-103853
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: January 4, 2012
• Start date: August 2004
• Est. completion date: June 2010

Study information

• Verified date: January 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Exercise
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.

Locations

Country	Name	City	State
Switzerland	Department of Child and Adolescent, University Hospital of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial function		0-3-6-24 months	No
Secondary	Body composition		0-3-6-24 months	No
Secondary	Body mass index		0-3-6-24 months	No
Secondary	Cardiorespiratory fitness		0-3-6-24 months	No
Secondary	Physical activity		0-3-6-24 months	No
Secondary	Insulin resistance		0-3-6-24 months	No
Secondary	Blood lipids		0-3-6-24 months	No
Secondary	Biological markers of endothelial function		0-3-6-24 months	No
Secondary	High sensitive C-reactive protein		0-3-6-24 months	No
Secondary	Resting and ambulatory blood pressure		0-3-6-24 months	No