Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Cardiovascular disease, Endothelial function, Blood pressure, Exercise, Physical activity, Metabolic syndrome, Children, Pediatric
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
Sites / Locations
- Department of Child and Adolescent, University Hospital of Geneva
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Obese exercise
Obese Control
Lean Exercise
Lean Control
Arm Description
Outcomes
Primary Outcome Measures
Arterial function
Secondary Outcome Measures
Body composition
Body mass index
Cardiorespiratory fitness
Physical activity
Insulin resistance
Blood lipids
Biological markers of endothelial function
High sensitive C-reactive protein
Resting and ambulatory blood pressure
Full Information
NCT ID
NCT00801645
First Posted
December 2, 2008
Last Updated
January 4, 2012
Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00801645
Brief Title
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
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Cardiovascular disease, Endothelial function, Blood pressure, Exercise, Physical activity, Metabolic syndrome, Children, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese exercise
Arm Type
Experimental
Arm Title
Obese Control
Arm Type
No Intervention
Arm Title
Lean Exercise
Arm Type
Experimental
Arm Title
Lean Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arterial function
Time Frame
0-3-6-24 months
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
0-3-6-24 months
Title
Body mass index
Time Frame
0-3-6-24 months
Title
Cardiorespiratory fitness
Time Frame
0-3-6-24 months
Title
Physical activity
Time Frame
0-3-6-24 months
Title
Insulin resistance
Time Frame
0-3-6-24 months
Title
Blood lipids
Time Frame
0-3-6-24 months
Title
Biological markers of endothelial function
Time Frame
0-3-6-24 months
Title
High sensitive C-reactive protein
Time Frame
0-3-6-24 months
Title
Resting and ambulatory blood pressure
Time Frame
0-3-6-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Beghetti, PD
Organizational Affiliation
Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nathalie J Farpour-Lambert, MD
Organizational Affiliation
Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent, University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21142752
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.
Results Reference
derived
PubMed Identifier
20082930
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.
Results Reference
derived
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Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
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