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

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Nathalie Farpour-Lambert, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00801645
First received: December 2, 2008
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Arterial function [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Cardiorespiratory fitness [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Insulin resistance [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Blood lipids [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Biological markers of endothelial function [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • High sensitive C-reactive protein [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
  • Resting and ambulatory blood pressure [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: August 2004
Study Completion Date: June 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese exercise 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.
Other Name: Physical activity
No Intervention: Obese Control
Experimental: Lean Exercise 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.
Other Name: Physical activity
No Intervention: Lean Control

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

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801645

Locations
Switzerland
Department of Child and Adolescent, University Hospital of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Investigators
Study Director: Maurice Beghetti, PD Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva
Principal Investigator: Nathalie J Farpour-Lambert, MD Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nathalie Farpour-Lambert, Head of the Obesity Care Program, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00801645     History of Changes
Other Study ID Numbers: SNF 3200B0-103853
Study First Received: December 2, 2008
Last Updated: January 4, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Obesity
Cardiovascular disease
Endothelial function
Blood pressure
Exercise
Physical activity
Metabolic syndrome
Children
Pediatric

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Syndrome X
Obesity
Syndrome
Body Weight
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014