Vascular Effects of a Single Bout of Electronic Cigarette Use

Arterial Stiffness Clinical Trial

Official title:

Vascular Effects of a Single Bout of Electronic Cigarette Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209661
• Other study ID #: 2016-04-0115
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating the acute effects of a single use E-Cigarette upon vascular health.

Description:

Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the effects upon to measures of vascular health. These measures will include Cardio-Ankle Vascular Index and Flow Mediated Dilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Apparently healthy, with no cardiovascular or metabolic diseases. Additionally, is not a frequent smoker of any kind.

Exclusion Criteria:

• Cardiovascular or Metabolic Diseases and/or regular smoker.

Related Conditions & MeSH terms

• Arterial Stiffness

Intervention

Drug:
• E-cigarette
E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.
• Nicotine 0%
E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.
• Menthol Inhalant Product
Menthol inhaler will be administered to determine the effects on vascular function.

Locations

Country	Name	City	State
United States	Cardiovascular Aging Research Lab at UT Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in arterial stiffness and endothelial function with e-cigarette use.	Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction	Immediately Post, 1 hour, and 2 hour.