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Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

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ClinicalTrials.gov Identifier: NCT03616002
Recruitment Status : Terminated (Due tot he Pandemic we decided to terminate this project.)
First Posted : August 6, 2018
Last Update Posted : February 4, 2021
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, San Francisco
Information provided by (Responsible Party):
Florian Rader, Cedars-Sinai Medical Center

Study Description
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Brief Summary:
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.

Condition or disease Intervention/treatment Phase
Hookah Smoking Other: Hookah smoking Not Applicable

Detailed Description:
The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Hookah Smoking on Vascular Regulation: Novel Insight Into Endothelial Function
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hookah smoking
Healthy habitual Hookah smokers will undergo brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry or pulse tonometry before and after Hookah smoking.
 Other: Hookah smoking
ad lib hookah smoking for 30 minutes in a controlled laboratory environment.


Outcome Measures
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Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: change from baseline to immediately after smoking ]

Secondary Outcome Measures :
  1. Reactive hyperemia peripheral arterial tonometry [ Time Frame: change from baseline to immediately after smoking ]

Other Outcome Measures:
  1. Pulse wave velocity [ Time Frame: change from baseline to immediately after smoking ]
  2. aortic pressure waveform [ Time Frame: change from baseline to immediately after smoking ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 29 years of age
  • Habitual Hookah smoker defined as having smoked Hookah >=12 times in the past 12 months
  • Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

  • History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
  • Exhaled carbon monoxide level >10 ppm
  • BP < 140/90 mmHg
  • BMI <18.5 or > 30 kg•m2
  • Resting heart rate > 100 beats/min
  • Taking prescription medication
  • History of illicit drug use
  • Pregnant
Contacts and Locations
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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): NCT03616002


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, Los Angeles
University of California, San Francisco
Investigators
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Principal Investigator: Florian Rader, MD Cedars-Sinai Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Florian Rader, M.D, M.Sc., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03616002    
Other Study ID Numbers: Pro00036547
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No