Study of Bronchial Inflammation in Adolescent Smokers With and Without Obesity

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00942019
First received: July 17, 2009
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

The investigators want to assess differences in lung function and bronchial inflammation of young smokers and non-smokers with (BMI > 30) and without obesity (BMI < 25)(4 patient groups). The aim of the study is to compare differences in lung function (VC, FEV1, VC/FEV1, metacholine challenge) and bronchial inflammation in relation with smoking history and levels of exhaled CO. For the latter the investigators will analyze the levels of IL-8, IL-6, TNF alpha and INF gamma and mRNA of LBP, TLR2 and TLR4 in sputum. Further, inflammatory markers e.g. low CRP and inflammatory cytokines levels in the blood will be investigated. The aim is to describe a early stage of chronic obstructive pulmonary disease caused by cigarette smoke in juvenile smokers, and the relationship between bronchial inflammation and obesity in adolescents.


Condition
Obesity
Tobacco Smoking

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Bronchial Inflammation in Adolescent Smokers With and Without Obesity

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Bronchial inflammatory in adolescents smokers with and without obesity [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of bronchial inflammatory parameters in sputum and in the blood [ Time Frame: one day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum: total IgE, RAST urin: cotinine, leukotrienes sputum: leukotrienes, white cells whole blood


Enrollment: 110
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
obese smokers
BMI > 30 kg/m2 CO ≥ 15 ppm
non-obese smokers
BMI < 25 kg/m2 CO ≥ 15 ppm
obese non-smokers
BMI > 30 kg/m2 CO ≤ 6 ppm
non-obese non-smokers
BMI < 25 kg/m2 CO ≤ 6 ppm

Detailed Description:

Tobacco smoke is the crucial factor at the beginning and in the course of the bronchial inflammation leading to COPD. It has been shown that cigarette smoke in vitro leads to a MAP kinase and NF-κB-dependent increase of pro-inflammatory cytokines, and inhibits bacteria-induced expression of β-defensins. Several studies revealed an increase of inflammatory cytokines like IL-8 and TNF in the sputum of smokers. Further studies demonstrated an up regulation of LTB4 and LBP possibly due to the LPS derived from tobacco smoke. Hasday et al could show that up to 15 ng per cigarette LPS is released. In principle, the cigarette smoke exposure liked a mild LPS inhalation. In separate work, we could show that LPS inhalation in healthy non-smokers to an increase of CRP and LBP concentrations in the serum lead. In another study of adolescents, 24 smokers (age 17.7 years) and 24 non-smoking (age 17.5 years) were compared. The CO in smokers was significantly increased, and the NO concentrations decreased. At the same time there was a significantly greater bronchial hyperreagibility in the smoker group.

According to a recent study in Germany (KiGGS study), already 31% of the adolescents' boys and 32% of the girls do smoke. The social status is of great importance. Boys and girls from families with a low social status smoke more frequently than those from families with middle-and especially with higher social status. Similarly obesity is linked to the social status with overweight occurring more often in families with a lower social status.

A visceral obesity is closely associated with the risk of type-2-diabetes as well as other aspects of the metabolic syndrome. However, the existing insulin resistance is of fundamental importance. Due to increased visceral fat depots and subsequently increased release of proinflammatory proteins various complications do occur.

  Eligibility

Ages Eligible for Study:   14 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Youth

Criteria

Inclusion Criteria:

  • informed consent
  • age between 14 and 22 years
  • smokers CO ≥ 15 ppm
  • non-smokers CO ≤ 6 ppm

Exclusion Criteria:

  • Asthma > GINA I°
  • others chronic diseases or infections (e.x. HIV, tuberculosis, malignancy)
  • pregnancy
  • therapy with systemic corticosteroids
  • permanent treatment with inhaled corticosteroids
  • documented alcohol, substance, and/or drug abuse
  • incapability to perform all study procedure
  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: NCT00942019

Locations
Germany
Children's Hospital, Goethe-University
Frankfurt/Main, Germany, 60596
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, Prof. Children´s Hospital, Goethe-University, Frankfurt, Germany
  More Information

Publications:
Responsible Party: Prof. Stefan Zielen, Goethe-University, Frankfurt, Germany
ClinicalTrials.gov Identifier: NCT00942019     History of Changes
Other Study ID Numbers: KGU-88/08
Study First Received: July 17, 2009
Last Updated: July 2, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
BMI
obesity
CO
tobacco smoking
adolescents

Additional relevant MeSH terms:
Inflammation
Obesity
Smoking
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Habits

ClinicalTrials.gov processed this record on July 29, 2014