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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00801645 |
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Date of registration:
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02/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
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Scientific title:
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Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00801645 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Maurice Beghetti, PD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva |
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Name:
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Nathalie J Farpour-Lambert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
11 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Exercise
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Primary Outcome(s)
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Arterial function
[Time Frame: 0-3-6-24 months]
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Secondary Outcome(s)
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Body mass index
[Time Frame: 0-3-6-24 months]
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Cardiorespiratory fitness
[Time Frame: 0-3-6-24 months]
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Biological markers of endothelial function
[Time Frame: 0-3-6-24 months]
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Blood lipids
[Time Frame: 0-3-6-24 months]
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Body composition
[Time Frame: 0-3-6-24 months]
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High sensitive C-reactive protein
[Time Frame: 0-3-6-24 months]
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Resting and ambulatory blood pressure
[Time Frame: 0-3-6-24 months]
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Physical activity
[Time Frame: 0-3-6-24 months]
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Insulin resistance
[Time Frame: 0-3-6-24 months]
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Secondary ID(s)
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SNF 3200B0-103853
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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