NCT02937415

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

December 19, 2015

Last Update Submit

October 16, 2016

Conditions

Keywords

carbon monoxideoxidative stresswaterpipe smokingcigarette smokingpulmonary function test

Outcome Measures

Primary Outcomes (1)

  • Breath Carbon Monoxide Level

    Levels of CO in breath will be measured in either waterpipe smokers or control group.

    Up to 4 months

Secondary Outcomes (11)

  • A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement.

    Up to 4 months

  • A spirometric Test; FVC (Forced Vital Capacity) Measurement.

    Up to 4 months

  • A spirometric Test; FEV1/FVC (Forced Expiratory Volume in One Second/Forced Vital Capacity) Measurement.

    Up to 4 months

  • A spirometric Test; PEF (Peak Expiratory Flow) Measurement.

    Up to 4 months

  • A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement.

    Up to 4 months

  • +6 more secondary outcomes

Study Arms (2)

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.

Procedure: Breath carbon monoxideProcedure: 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.

Procedure: Breath carbon monoxideProcedure: Pulmonary function tests.Procedure: Oxidative stress and antioxidant status.

Interventions

Breath carbon monoxide measurement.

Control groupWaterpipe smokers group

Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.

Also known as: Spirometry
Control groupWaterpipe smokers group

Measurement of parameters of oxidative stress and antioxidant status in blood samples.

Control groupWaterpipe smokers group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who haven't determined major health problems,
  • between ages 18-40.

You may not qualify if:

  • Participants who under age 18 and above 40,
  • pregnant women,
  • individuals who have major health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Water Pipe SmokingCigarette Smoking

Interventions

Respiratory Physiological PhenomenaOxidative Stress

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehaviorTobacco SmokingTobacco Use

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological PhenomenaMetabolismStress, PhysiologicalPhysiological Phenomena

Study Officials

  • Ozcan Erel, Prof. M.D.

    Ankara Yildirim Beyazit University, Medical School, Director of Biochemistry Department, Ankara, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mukremin Er, MD.

Study Record Dates

First Submitted

December 19, 2015

First Posted

October 18, 2016

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

October 18, 2016

Record last verified: 2016-10