Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.

Endothelial Dysfunction Clinical Trial

Official title:

Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301129
• Other study ID #: 3241
• Status: Completed
• Phase: N/A
• First received: September 23, 2017
• Last updated: March 26, 2018
• Start date: October 15, 2017
• Est. completion date: February 25, 2018

Study information

• Verified date: March 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 25, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smokers volunteers, minimum age 18 years

Exclusion Criteria:

• no history of acute or chronic organic, metabolic and inflammatory diseases;

• no fever and infections in the last 3 months;

• no history of cardiovascular pathological symptoms;

• no allergies;

• none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD

• women were not menstruating when the experiment was performed.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Oxidative Stress Induction
• Platelet Activation

Intervention

Behavioral:
• Smoke
See arm/group descriptions.

Locations

Country	Name	City	State
Italy	Sapienza University	Roma

Sponsors (10)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Chimenti Isotta, Coluzzi Flaminia, De Falco Elena, Loffredo Lorenzo, Marullo Antonino G.M., Nocella Cristina, Peruzzi Mariangela, Sciarretta Sebastiano, Valenti Valentina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial dysfunction	flow-mediated dilatation (FMD) assessed by vascular ultrasound	up to 24 weeks
Primary	Oxidative stress	Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation	up to 24 weeks
Secondary	Platelet activation	evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation	up to 24 weeks