Carbon Monoxide and Oxidative Stress in Waterpipe Smokers

October 16, 2016 updated by: Mukremin Er, Ataturk Training and Research Hospital

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Spirometry
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:
  • Spirometry
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ozcan Erel, Prof. M.D., Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

December 19, 2015

First Submitted That Met QC Criteria

October 16, 2016

First Posted (ESTIMATE)

October 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 16, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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