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The Impact of Obesity on Children and Adolescents.

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ClinicalTrials.gov Identifier: NCT01231152
Recruitment Status : Unknown
Verified May 2012 by George S. Stergiou, University of Athens.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens

Brief Summary:
The aim of the study is to investigate the association of obesity with arterial blood pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin resistance in children and young adolescents.

Condition or disease
Obesity Cardiovascular Risk Factors

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Relation of Obesity With Metabolic Disorders, Inflammation Markers and Arterial Blood Pressure With Preclinical Target-organ Damage in Children and Young Adolescents.
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012



Primary Outcome Measures :
  1. Blood Pressure levels, Target organ damage (Left Ventricular Hypertrophy, IMT, pulse wave velocity, microalbuminuria), Insulin Resistance [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents referred for increased body weight.
Criteria

Inclusion Criteria:

  • Overweight (85th<BMI<95th percentile) and obese (BMI>=95th percentile) children and adolescents
  • No medication treatment (apart from bronchodilators, T4 in euthyroid children)
  • No severe mental problem
  • Parents' and patients' signed consent

Exclusion Criteria:

  • Severe chronic or acute cardiac disease or other severe chronic or acute disease
  • Any acute inflammation
  • Familial dyslipidemia
  • Clinical hypothyroidism or other endocrinopathy
  • Poor compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231152


Locations
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Greece
Hypertension Center, Third Department of Medicine, University of Athens Recruiting
Athens, Greece
Contact: George S Stergiou, MD    +302107763117    gstergi@med.uoa.gr   
Principal Investigator: George S Stergiou, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: George S Stergiou University of Athens
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Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT01231152    
Other Study ID Numbers: OB10
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms