Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03616002
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, San Francisco
Information provided by (Responsible Party):
Ron Victor, Cedars-Sinai Medical Center

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Mohamad Rashid, CCRC 4243152501 MOHAMAD.RASHID@CSHS.ORG

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mohamad Rashid, CCRC    310-248-7641    mohamad.rashid@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, Los Angeles
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Ronald Victor, MD Cedars-Sinai Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ron Victor, Professor of Medicine, Cedars-Sinai Medical Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03616002     History of Changes
Other Study ID Numbers: Pro00036547
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No