- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937415
Carbon Monoxide and Oxidative Stress in Waterpipe Smokers
Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers
Study Overview
Status
Conditions
Detailed Description
Waterpipe or hookah uses a different kind of tobacco, which is available in most Balkan countries, Middle East and South Asia. Popularity of smoking waterpipe among European, Canadian, and American young people has shown a dramatic rise over the past decade. The growing popularity of waterpipe use among U.S. teens and adults is evidenced by media reports and the recent rapid proliferation of waterpipe establishments (bars, cafes, or restaurants) in large cities and near college campuses. Typical waterpipes have the following components; a bowl where the tobacco is placed and heated, usually with burning embers or charcoal, a vase or smoke chamber which is partially filled with water, a pipe or stem connecting the bowl to the vase by a tube that carries the smoke down into the water, and a hose with a mouthpiece through which the smoke is drawn from the vase. As the smoker inhales, the tobacco smoke is sucked down from the bowl and then bubbles up through the water into the air of the smoke chamber and then through the hose to the smoker. At the end of a smoking session, the dirty water is thrown away and the waterpipe vase is refilled for the next user. Although each smoking session generally lasts about 45 to 60 minutes, it can also continue for several hours.
There is a misconception about smoking waterpipe that it is less harmful than cigarettes, and that's why smoking waterpipe is dramatically increasing especially among young people. While the adverse effects of smoking cigarette are widely described, there are just a few investigations about waterpipe and its effects. This study was designed to investigate the effects of smoking waterpipe on pulmonary functions and oxidative stress parameters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants who haven't determined major health problems,
- between ages 18-40.
Exclusion Criteria:
- Participants who under age 18 and above 40,
- pregnant women,
- individuals who have major health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Waterpipe smokers group
Three waterpipe cafes located in Ankara were visited.
50 waterpipe smokers aged 18-40 years, enrolled in the study and created the working group.
At the same time, there were also cigarette smokers among these people.
Breath carbon monoxide, pulmonary function tests were performed both before and after smoking waterpipe and parameters of oxidative stress and antioxidant status were measured in blood samples after smoking waterpipe.
|
Breath carbon monoxide measurement.
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
Other Names:
Measurement of parameters of oxidative stress and antioxidant status in blood samples.
|
ACTIVE_COMPARATOR: Control group
The control group consisted of 50 people of the same age and sex, who had never smoked neither cigarette nor waterpipe.
Breath carbon monoxide, pulmonary function tests were performed and parameters of oxidative stress were measured in blood samples.
|
Breath carbon monoxide measurement.
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
Other Names:
Measurement of parameters of oxidative stress and antioxidant status in blood samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breath Carbon Monoxide Level
Time Frame: Up to 4 months
|
Levels of CO in breath will be measured in either waterpipe smokers or control group.
|
Up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement.
Time Frame: Up to 4 months
|
FEV1 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
A spirometric Test; FVC (Forced Vital Capacity) Measurement.
Time Frame: Up to 4 months
|
FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
A spirometric Test; FEV1/FVC (Forced Expiratory Volume in One Second/Forced Vital Capacity) Measurement.
Time Frame: Up to 4 months
|
FEV1/FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
A spirometric Test; PEF (Peak Expiratory Flow) Measurement.
Time Frame: Up to 4 months
|
PEF Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement.
Time Frame: Up to 4 months
|
FEF25-75 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma TAS (Total Anti-Oxydant Status) Measurement.
Time Frame: Up to 4 months
|
To Assessment of Anti-Oxidant Status: TAS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma TOS (Total Oxydative Stress) Measurement.
Time Frame: Up to 4 months
|
To Assessment of Oxidative Stress: TOS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma OSI Measurement.
Time Frame: Up to 4 months
|
To Assessment of Antioxidant Status: TAS (Total Anti-oxydative Status) Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma PON (Paraoxonase) Measurement.
Time Frame: Up to 4 months
|
To Assessment of Antioxidant Status: PON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma sPON (Stimulated Paraoxonase) Measurement.
Time Frame: Up to 4 months
|
To Assessment of Antioxidant Status: sPON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Plasma ARES (Arylesterase) Measurement.
Time Frame: Up to 4 months
|
To Assessment of Arylesterase Activity: ARES Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
|
Up to 4 months
|
Collaborators and Investigators
Investigators
- Study Director: Ozcan Erel, Prof. M.D., Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey
Publications and helpful links
General Publications
- Mokdad AH, Warren CW. As if cigarettes were not enough, here comes narghile. A commentary on an article by Yunis et al. in IJPH 52/4. Int J Public Health. 2007;52(5):263-4. doi: 10.1007/s00038-007-0221-6. No abstract available.
- Maziak W. The global epidemic of waterpipe smoking. Addict Behav. 2011 Jan-Feb;36(1-2):1-5. doi: 10.1016/j.addbeh.2010.08.030. Epub 2010 Oct 8.
- Maziak W, Ward KD, Afifi Soweid RA, Eissenberg T. Tobacco smoking using a waterpipe: a re-emerging strain in a global epidemic. Tob Control. 2004 Dec;13(4):327-33. doi: 10.1136/tc.2004.008169.
- Dugas E, Tremblay M, Low NC, Cournoyer D, O'Loughlin J. Water-pipe smoking among North American youths. Pediatrics. 2010 Jun;125(6):1184-9. doi: 10.1542/peds.2009-2335. Epub 2010 May 10.
- Shafagoj YA, Mohammed FI. Levels of maximum end-expiratory carbon monoxide and certain cardiovascular parameters following hubble-bubble smoking. Saudi Med J. 2002 Aug;23(8):953-8.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AtaturkTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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