Clinical trial NCT02937415: Carbon Monoxide and Oxidative Stress in Waterpipe Smokers
Official title: Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Smoking
Oxidative Stress
Keywords: carbon monoxide
oxidative stress
waterpipe smoking
cigarette smoking
pulmonary function test
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Waterpipe is a tool for smoking tobacco, which is thought to be less harmful than cigarette. Unfortunately, there aren't adequate studies about its harms to health that are threatening the young generation all over the world today. The objective of this study was to show the carbon monoxide (CO) levels in waterpipe smokers' breaths, whether can be used or not to reflect the changes of oxidative stress for this reason to predict harmful effects on the pulmonary functions.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Breath Carbon Monoxide Level
timeFrame: Up to 4 months
Secondary outcomes:
measure: A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement.
timeFrame: Up to 4 months
measure: A spirometric Test; FVC (Forced Vital Capacity) Measurement.
timeFrame: Up to 4 months
measure: A spirometric Test; FEV1/FVC (Forced Expiratory Volume in One Second/Forced Vital Capacity) Measurement.
timeFrame: Up to 4 months
measure: A spirometric Test; PEF (Peak Expiratory Flow) Measurement.
timeFrame: Up to 4 months
measure: A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement.
timeFrame: Up to 4 months
measure: Plasma TAS (Total Anti-Oxydant Status) Measurement.
timeFrame: Up to 4 months
measure: Plasma TOS (Total Oxydative Stress) Measurement.
timeFrame: Up to 4 months
measure: Plasma OSI Measurement.
timeFrame: Up to 4 months
measure: Plasma PON (Paraoxonase) Measurement.
timeFrame: Up to 4 months
measure: Plasma sPON (Stimulated Paraoxonase) Measurement.
timeFrame: Up to 4 months
measure: Plasma ARES (Arylesterase) Measurement.
timeFrame: Up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey
name: Ozcan Erel, Prof. M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.