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The Relation Between Obesity, Adipose Tissue Content of Fatty Acids and Systemic and Airway Inflammation

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Cyprus International Institute for Environment and Public Health
ClinicalTrials.gov Identifier:
NCT01229787
First received: October 27, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

Obesity has been recognized as a risk factors for developing asthma. In a cohort of 5384 children aged 15-17, we aim to:

  1. To investigate the association of asthma prevalence at age 15-17 with body mass index (BMI) at age 15-17 and BMI at age 11-12 years Part II

  2. To investigate the association of BMI in adolescence and BMI at age 11-12 years with:

    1. Prevalence of allergic sensitization
    2. Lung function
    3. Levels of airway inflammation at age 16-18 years
    4. Severity of asthma

Secondly, to assess diet and physical activity involvement as effect modifiers in these possible associations.


Condition
Asthma, Allergies and Obesity

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Relation Between Obesity, Adipose Tissue Content of Fatty Acids and Systemic and Airway Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma Obesity
U.S. FDA Resources

Further study details as provided by Cyprus International Institute for Environment and Public Health:

Primary Outcome Measures:
  • The association between asthma prevalence in adolescence and obsity in adolescence and in childhood [ Designated as safety issue: No ]
    To investigate the association of asthma prevalence at age 15-17 with body mass index (BMI) at age 15-17 and at age 11-12 years


Secondary Outcome Measures:
  • Association of BMI in adolescence and in childhood with allergic sensitization and lung function [ Designated as safety issue: No ]

    To investigate the association of BMI in adolescence and BMI at age 11-12 years with:

    1. Prevalence of allergic sensitization
    2. Lung function
    3. Levels of airway inflammation at age 16-18 years
    4. Severity of asthma


Enrollment: 5384
Study Start Date: January 2007
Study Completion Date: December 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Part I took place in 2007 and children 15-16 and 16-17 years across Cyprus were invited to participate. The targeted population were 19849 children that participated in an earlier study in years 2001-3 and had anthropometric measurements, assessment of cardio-respiratory fitness and serum lipids taken at that time. The subjects of the second part of the study were selected from the 5384 subjects that had participated in the first part and had matched data on current and past BMI. We targeted subjects for part two of the study with the following criteria:1. Current Wheezers: All active asthmatics across all BMI subgroups. Definition of Current Wheezer: Positive answer to the question in ISAAC questionnaire: "Have you had wheezing in the past 12 months?" 2. Never Wheezers: 700 controls selected in a random way across all BMI groups. Definition of Never Wheezer: Negative answers to both of the following two questions: "Have you ever had wheezing?" and "Have you ever had asthma?"

Criteria

Inclusion Criteria:

  • not applicable

Exclusion Criteria:

  • not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229787

Locations
Cyprus
Cyprus International insitute
Nicosia, Cyprus
Sponsors and Collaborators
Cyprus International Institute for Environment and Public Health
Merck
Investigators
Principal Investigator: Panayiotis Yiallouros, MD, PhD Cyprus International Insitute
  More Information

No publications provided

Responsible Party: Dr Panayiotis Yiallouros, Cyprus International Institute for the Environment and Public Health
ClinicalTrials.gov Identifier: NCT01229787     History of Changes
Other Study ID Numbers: CIIRespiratory1
Study First Received: October 27, 2010
Last Updated: October 27, 2010
Health Authority: Cyprus: Cyprus National Bioethics Committee

Keywords provided by Cyprus International Institute for Environment and Public Health:
asthma
allergies
obesity

Additional relevant MeSH terms:
Asthma
Inflammation
Obesity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013