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Carbon Monoxide and Oxidative Stress in Waterpipe Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02937415
First Posted: October 18, 2016
Last Update Posted: October 18, 2016
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.
Information provided by (Responsible Party):
Mukremin Er, Ataturk Training and Research Hospital
  Purpose
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.

Condition Intervention
Waterpipe Smoking Oxidative Stress Procedure: Breath carbon monoxide Procedure: Pulmonary function tests. Procedure: Oxidative stress and antioxidant status.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers

Resource links provided by NLM:


Further study details as provided by Mukremin Er, Ataturk Training and Research Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 100
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Breath carbon monoxide
Breath carbon monoxide measurement.
Procedure: Pulmonary function tests.
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
Other Name: Spirometry
Procedure: Oxidative stress and antioxidant status.
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.
Procedure: Breath carbon monoxide
Breath carbon monoxide measurement.
Procedure: Pulmonary function tests.
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
Other Name: Spirometry
Procedure: Oxidative stress and antioxidant status.
Measurement of parameters of oxidative stress and antioxidant status in blood samples.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02937415


Sponsors and Collaborators
Ataturk Training and Research Hospital
Investigators
Study Director: Ozcan Erel, Prof. M.D. Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey
  More Information

Publications:
Responsible Party: Mukremin Er, Mukremin Er, MD., Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02937415     History of Changes
Other Study ID Numbers: AtaturkTRH
First Submitted: December 19, 2015
First Posted: October 18, 2016
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mukremin Er, Ataturk Training and Research Hospital:
carbon monoxide
oxidative stress
waterpipe smoking
cigarette smoking
pulmonary function test

Additional relevant MeSH terms:
Antioxidants
Carbon Monoxide
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimetabolites
Gasotransmitters
Neurotransmitter Agents