Study of Bronchial Inflammation in Adolescent Smokers With and Without Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942019
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : July 5, 2010
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
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 or disease
Obesity Tobacco Smoking

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.

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Bronchial Inflammation in Adolescent Smokers With and Without Obesity
Study Start Date : October 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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

Primary Outcome Measures :
  1. Bronchial inflammatory in adolescents smokers with and without obesity [ Time Frame: one day ]

Secondary Outcome Measures :
  1. Association of bronchial inflammatory parameters in sputum and in the blood [ Time Frame: one day ]

Biospecimen Retention:   Samples With DNA
serum: total IgE, RAST urin: cotinine, leukotrienes sputum: leukotrienes, white cells whole blood

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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 identifier (NCT number): NCT00942019

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

Responsible Party: Prof. Stefan Zielen, Goethe-University, Frankfurt, Germany Identifier: NCT00942019     History of Changes
Other Study ID Numbers: KGU-88/08
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: July 2010

Keywords provided by Johann Wolfgang Goethe University Hospital:
tobacco smoking

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes