ObesityNCT00942019
Study of Bronchial Inflammation in Adolescent Smokers With and Without Obesity
An observational study of Obesity and Tobacco Smoking, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Tobacco Smoking
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Youth
Who may be able to join
- informed consent
- age between 14 and 22 years
- smokers CO ≥ 15 ppm
- non-smokers CO ≤ 6 ppm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchial Inflammation in Adolescent Smokers With and Without Obesity
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.
Read the 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.
- Conditions
- Obesity, Tobacco Smoking
- Keywords
- BMI, obesity, CO, tobacco smoking, adolescents
- Medical subject headings
- Obesity, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial inflammatory in adolescents smokers with and without obesity
Measured: one day
Secondary outcomes (1)
Association of bronchial inflammatory parameters in sputum and in the blood
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Zielen, Prof., Principal investigator, Children´s Hospital, Goethe-University, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942019
- Sponsor's protocol ID
- KGU-88/08
- Status last verified
- Jul 2010
- First submitted
- 17 Jul 2009
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Karimi K, Sarir H, Mortaz E, Smit JJ, Hosseini H, De Kimpe SJ, Nijkamp FP, Folkerts G. Toll-like receptor-4 mediates cigarette smoke-induced cytokine production by human macrophages. Respir Res. 2006 Apr 19;7(1):66. doi: 10.1186/1465-9921-7-66.
PubMed 16620395Carpagnano GE, Kharitonov SA, Foschino-Barbaro MP, Resta O, Gramiccioni E, Barnes PJ. Increased inflammatory markers in the exhaled breath condensate of cigarette smokers. Eur Respir J. 2003 Apr;21(4):589-93. doi: 10.1183/09031936.03.00022203.
PubMed 12762340Garey KW, Neuhauser MM, Robbins RA, Danziger LH, Rubinstein I. Markers of inflammation in exhaled breath condensate of young healthy smokers. Chest. 2004 Jan;125(1):22-6. doi: 10.1378/chest.125.1.22.
PubMed 14718416Csoma Z, Kharitonov SA, Balint B, Bush A, Wilson NM, Barnes PJ. Increased leukotrienes in exhaled breath condensate in childhood asthma. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1345-9. doi: 10.1164/rccm.200203-233OC. Epub 2002 Sep 5.
PubMed 12406853Sebastian A, Pehrson C, Larsson L. Elevated concentrations of endotoxin in indoor air due to cigarette smoking. J Environ Monit. 2006 May;8(5):519-22. doi: 10.1039/b600706f. Epub 2006 Mar 27.
PubMed 16688352Kitz R, Rose MA, Borgmann A, Schubert R, Zielen S. Systemic and bronchial inflammation following LPS inhalation in asthmatic and healthy subjects. J Endotoxin Res. 2006;12(6):367-74. doi: 10.1179/096805106X153934.
PubMed 17254391KiGGS Study of Robert Koch Institut
Kornmann O et al. Influence of second hand tobacco smoke exposure on inflammatory parameters in induced sputum Abstract ATS 2008
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Inflammation in Adolescent Smokers With and Without Obesity
- ClinicalTrials.gov ID
- NCT00942019
- Acronym / sponsor ID
- KGU-88/08
- Conditions
- Obesity, Tobacco Smoking
- Keywords
- BMI, obesity, CO, tobacco smoking, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Youth
Key inclusion criteria (4 listed)
- informed consent
- age between 14 and 22 years
- smokers CO ≥ 15 ppm
- non-smokers CO ≤ 6 ppm
Key exclusion criteria (7 listed)
- Asthma > GINA I°
- others chronic diseases or infections (e.x. HIV, tuberculosis, malignancy)
- pregnancy
- therapy with systemic corticosteroids
- permanent treatment with inhaled corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchial inflammatory in adolescents smokers with and without obesity
Time frame: one day
1 secondary outcome
Association of bronchial inflammatory parameters in sputum and in the blood
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
- Background: PubMed 16620395Karimi K, Sarir H, Mortaz E, Smit JJ, Hosseini H, De Kimpe SJ, Nijkamp FP, Folkerts G. Toll-like receptor-4 mediates cigarette smoke-induced cytokine production by human macrophages. Respir Res. 2006 Apr 19;7(1):66. doi: 10.1186/1465-9921-7-66.
- Background: PubMed 12762340Carpagnano GE, Kharitonov SA, Foschino-Barbaro MP, Resta O, Gramiccioni E, Barnes PJ. Increased inflammatory markers in the exhaled breath condensate of cigarette smokers. Eur Respir J. 2003 Apr;21(4):589-93. doi: 10.1183/09031936.03.00022203.
- Background: PubMed 14718416Garey KW, Neuhauser MM, Robbins RA, Danziger LH, Rubinstein I. Markers of inflammation in exhaled breath condensate of young healthy smokers. Chest. 2004 Jan;125(1):22-6. doi: 10.1378/chest.125.1.22.
- Background: PubMed 12406853Csoma Z, Kharitonov SA, Balint B, Bush A, Wilson NM, Barnes PJ. Increased leukotrienes in exhaled breath condensate in childhood asthma. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1345-9. doi: 10.1164/rccm.200203-233OC. Epub 2002 Sep 5.
- Background: PubMed 16688352Sebastian A, Pehrson C, Larsson L. Elevated concentrations of endotoxin in indoor air due to cigarette smoking. J Environ Monit. 2006 May;8(5):519-22. doi: 10.1039/b600706f. Epub 2006 Mar 27.
- Background: PubMed 17254391Kitz R, Rose MA, Borgmann A, Schubert R, Zielen S. Systemic and bronchial inflammation following LPS inhalation in asthmatic and healthy subjects. J Endotoxin Res. 2006;12(6):367-74. doi: 10.1179/096805106X153934.
- BackgroundKiGGS Study of Robert Koch Institut
- BackgroundKornmann O et al. Influence of second hand tobacco smoke exposure on inflammatory parameters in induced sputum Abstract ATS 2008
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Prof. principal investigator
Children´s Hospital, Goethe-University, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Tobacco Smoking, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial inflammatory in adolescents smokers with and without obesity (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00942019, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.