Waterpipe SmokingNCT02937415
Carbon Monoxide and Oxidative Stress in Waterpipe Smokers
A study testing Breath carbon monoxide, Pulmonary function tests. and Oxidative stress and antioxidant status. in people with Waterpipe Smoking and Oxidative Stress, run by Ataturk Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking, Oxidative Stress
- What is being tested?
- Breath carbon monoxide, Pulmonary function tests. and Oxidative stress and antioxidant status.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who haven't determined major health problems,
- between ages 18-40.
Who cannot join
- Participants who under age 18 and above 40,
- pregnant women,
- individuals who have major health problems
About this study
Official title: 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.
Read the 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.
- Conditions
- Waterpipe Smoking, Oxidative Stress
- Being tested
- Breath carbon monoxide, Pulmonary function tests., Oxidative stress and antioxidant status.
- Keywords
- carbon monoxide, oxidative stress, waterpipe smoking, cigarette smoking, pulmonary function test
- Medical subject headings
- Water Pipe Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath carbon monoxideProcedure or surgery
Breath carbon monoxide measurement.
Pulmonary function tests.Procedure or surgery
Also called Spirometry
Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
Oxidative stress and antioxidant status.Procedure or surgery
Measurement of parameters of oxidative stress and antioxidant status in blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Waterpipe smokers group | Experimental | 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. Receives: Procedure: Breath carbon monoxide; Procedure: Pulmonary function tests.; Procedure: Oxidative stress and antioxidant status. |
| Control group | Active comparator | 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. Receives: Procedure: Breath carbon monoxide; Procedure: Pulmonary function tests.; Procedure: Oxidative stress and antioxidant status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Carbon Monoxide Level
Levels of CO in breath will be measured in either waterpipe smokers or control group.
Measured: Up to 4 months
Secondary outcomes (11)
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
Plasma PON (Paraoxonase) Measurement.
To Assessment of Antioxidant Status: PON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
Measured: Up to 4 months
Plasma sPON (Stimulated Paraoxonase) Measurement.
To Assessment of Antioxidant Status: sPON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
Measured: Up to 4 months
Plasma ARES (Arylesterase) Measurement.
To Assessment of Arylesterase Activity: ARES Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Waterpipe SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukremin Er, Ataturk Training and Research Hospital
- Investigators
- Ozcan Erel, Prof. M.D., Study director, Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937415
- Sponsor's protocol ID
- AtaturkTRH
- Status last verified
- Oct 2016
- First submitted
- 19 Dec 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 18030938Maziak 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.
PubMed 20888700Maziak 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.
PubMed 15564614Dugas 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.
PubMed 20457679Shafagoj 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.
PubMed 12235470
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers
- ClinicalTrials.gov ID
- NCT02937415
- Acronym / sponsor ID
- AtaturkTRH
- Conditions
- Waterpipe Smoking, Oxidative Stress
- Keywords
- carbon monoxide, oxidative stress, waterpipe smoking, cigarette smoking, pulmonary function test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waterpipe smokers group | Experimental | Procedure: Breath carbon monoxide, Procedure: Pulmonary function tests., Procedure: Oxidative stress and antioxidant status.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. |
| Control group | Active comparator | Procedure: Breath carbon monoxide, Procedure: Pulmonary function tests., Procedure: Oxidative stress and antioxidant status.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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants who haven't determined major health problems,
- between ages 18-40.
Key exclusion criteria (3 listed)
- Participants who under age 18 and above 40,
- pregnant women,
- individuals who have major health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath carbon monoxideBreath carbon monoxide measurement. | Procedure or surgery | Control group, Waterpipe smokers group |
| Pulmonary function tests.Also: SpirometryMeasurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs. | Procedure or surgery | Control group, Waterpipe smokers group |
| Oxidative stress and antioxidant status.Measurement of parameters of oxidative stress and antioxidant status in blood samples. | Procedure or surgery | Control group, Waterpipe smokers group |
Primary outcome
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.
11 secondary outcomes
A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement.
Time frame: Up to 4 months
A spirometric Test; FVC (Forced Vital Capacity) Measurement.
Time frame: 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
A spirometric Test; PEF (Peak Expiratory Flow) Measurement.
Time frame: Up to 4 months
A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement.
Time frame: Up to 4 months
Plasma TAS (Total Anti-Oxydant Status) Measurement.
Time frame: Up to 4 months
Plasma TOS (Total Oxydative Stress) Measurement.
Time frame: Up to 4 months
Plasma OSI Measurement.
Time frame: Up to 4 months
Plasma PON (Paraoxonase) Measurement.
Time frame: Up to 4 months
Plasma sPON (Stimulated Paraoxonase) Measurement.
Time frame: Up to 4 months
Plasma ARES (Arylesterase) Measurement.
Time frame: Up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Results publication: PubMed 18030938Mokdad 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.
- Results publication: PubMed 20888700Maziak 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.
- Results publication: PubMed 15564614Maziak 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.
- Results publication: PubMed 20457679Dugas 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.
- Results publication: PubMed 12235470Shafagoj 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.
- Individual participant dataSharing planned: Undecided
Related trials for Waterpipe Smoking
Recruiting
Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Lung Cancer, Lung Neoplasms
Active, not recruiting
Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol
Hookah Smoking, Secondhand Aerosol
Not yet recruiting
Evaluating the Efficacy of a Text Messaging-based Shisha Smoking Cessation Intervention
Intervention, Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozcan Erel, Prof. M.D. study director
Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey
Questions about this trial
What is this clinical trial studying?
A study testing Breath carbon monoxide, Pulmonary function tests. and Oxidative stress and antioxidant status. in people with Waterpipe Smoking and Oxidative Stress, run by Ataturk Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Carbon Monoxide Level (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937415, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.