Carbon Monoxide and Oxidative Stress in Waterpipe Smokers

Oxidative Stress Clinical Trial

Official title:

Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937415
• Other study ID #: AtaturkTRH
• Status: Completed
• Phase: N/A
• First received: December 19, 2015
• Last updated: October 16, 2016
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2016
• Source: Ataturk Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Oxidative Stress
• Waterpipe Smoking

Intervention

Procedure:
• Breath carbon monoxide
Breath carbon monoxide measurement.
• Pulmonary function tests.
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
• Oxidative stress and antioxidant status.
Measurement of parameters of oxidative stress and antioxidant status in blood samples.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Carbon Monoxide Level	Levels of CO in breath will be measured in either waterpipe smokers or control group.	Up to 4 months	No
Secondary	A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement.	FEV1 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	A spirometric Test; FVC (Forced Vital Capacity) Measurement.	FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	A spirometric Test; FEV1/FVC (Forced Expiratory Volume in One Second/Forced Vital Capacity) Measurement.	FEV1/FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	A spirometric Test; PEF (Peak Expiratory Flow) Measurement.	PEF Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement.	FEF25-75 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	Plasma TAS (Total Anti-Oxydant Status) Measurement.	To Assessment of Anti-Oxidant Status: TAS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	Plasma TOS (Total Oxydative Stress) Measurement.	To Assessment of Oxidative Stress: TOS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	Plasma OSI Measurement.	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	No
Secondary	Plasma PON (Paraoxonase) Measurement.	To Assessment of Antioxidant Status: PON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	Plasma sPON (Stimulated Paraoxonase) Measurement.	To Assessment of Antioxidant Status: sPON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.	Up to 4 months	No
Secondary	Plasma ARES (Arylesterase) Measurement.	To Assessment of Arylesterase Activity: ARES Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.	Up to 4 months	No