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

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Oxidative Stress Induction; Platelet Activation
• Interventions: Behavioral: Smoke

• Registration Number: NCT03301129
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-23
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-04
• Study Start: 2017-10-15
• Primary Completion: 2018-01-30
• Study Completion: 2018-02-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Heat-not-burn tobacco products (IQOS)	Smoke	smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).
Traditional cigarette	Smoke	smoke one Traditional cigarette (with a mean nicotine content of 0.6 mg according to package label) and in a sub-group smoke a sham cigarette (an traditional cigarette without combustion).
Electronic cigarette	Smoke	smoke a tobacco-flavored Electronic cigarette (9 puffs approximately equivalent to 0.6 mg of nicotine content) and in a sub-group smoke a sham cigarette (an electronic cigarette without nicotine).

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction	up to 24 weeks	flow-mediated dilatation (FMD) assessed by vascular ultrasound
Oxidative stress	up to 24 weeks	Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation

Secondary Outcome Measures

Name	Time	Method
Platelet activation	up to 24 weeks	evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation

Trial Locations

Locations (1)

Sapienza University; 🇮🇹 Roma, Italy