Trial document





This trial has been registered retrospectively.
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  DRKS00012919

Trial Description

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Title

Influences of different nicotine applications on peripheral and central hemodynamic as well as on arterial stiffness and endothelial dysfunction

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Trial Acronym

EZig

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to evaluate the effects of various nicotine applications (cigarette, e-cigarette, etc.) against an e-cigarette with a liquid without nicotine. Special blood pressure measurements as well as blood tests are performed with further processing of the blood samples to answer several questions. Each participant goes through each arm and was followed up for hours after smoking e.g. vaping for the tests.

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Brief Summary in Scientific Language

The present study is a simple blinded randomized study with control group. The study aims to evaluate the effects of the different application types of nicotine, such as filter cigarette and e-cigarette, on central hemodynamics (central blood pressure, pulse wave velocity, endothelial dysfunction as well as inflammatory parameters. In a second step the effects on the sympathetic nervous system should also be investigated. Therefore healthy volunteers who have to be active smokers should smoke three times at different times. The three times include the nicotine application with filter cigarette, nicotine delivery systems like e-cigarette with a high dose of nicotine as well as an IQOS. An e-cigarette without nicotine was used as a control group.
The methods used are: a) the measurement of the peripheral and central hemodynamic as well as arterial stiffness measured by Mobil-O-Graph (I.E.M, Stolberg, Germany), which is currently one of the few devices with which temporally high resolution hemodynamic parameters can be obtained clinically validated; b) laboratory diagnostics were used to investigate the effects on parameters of endothelial dysfunction and inflammation.

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Organizational Data

  •   DRKS00012919
  •   2017/08/29
  •   [---]*
  •   yes
  •   Approved
  •   15-171, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   I70.9 -  Generalized and unspecified atherosclerosis
  •   Smoker
  •   healthy volunteers
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Interventions/Observational Groups

  •   e-cigarette with nicotine (24 mg/ml)
  •   filter cigarette (nicotine - 0.7 mg)
  •   e-cigarette without nicotine
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the measurement of the nicotine concentration in the blood ten minutes after the nicotine application and during follow-up after one and two hours as well as the changes in blood pressure.

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Secondary Outcome

Secondary outcomes include changes in peripheral and central hemodynamics, arterial stiffness, endothelias dysfunction and inflammatory markers depending on the various nicotine applications for two hours after vaping e.g. smoking.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/01
  •   55
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

- age over 18 years
- active smoking
- written consent to the study protocol
- female smokers under oral contraceptives (to avoid hormonal/cyclic dependencies)

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Exclusion Criteria

- non smoking
- pregnancy or lactation
- drug or alcohol abuse
- participation in other clinical trials
- lack of compliance

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Dr.  Klaas F.  Franzen 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Dr  Klaas F.  Franzen 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.