Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03301129
Enrollment
20
Registered
2017-10-04
Start date
2017-10-15
Completion date
2018-02-25
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Oxidative Stress Induction, Platelet Activation

Brief 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.

Interventions

BEHAVIORALSmoke

See arm/group descriptions.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Endothelial dysfunctionup to 24 weeksflow-mediated dilatation (FMD) assessed by vascular ultrasound
Oxidative stressup to 24 weeksSoluble Nox2-derived peptide, a direct marker of NADPH oxidase activation

Secondary

MeasureTime frameDescription
Platelet activationup to 24 weeksevaluation of sPselectin, thromboxane and aggregation as markers of platelet activation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026