Clinical trial NCT02779127: Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers
Official title: Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers : Evaluation of Endothelial Vasomotoricity Before and After Cessation of Exposure to Passive Smoking : DILATER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Endothelium
Passive smoking
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Endothelium is considered a real member, so it is contributing to determine the vascular homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by non-invasive study of the variation of gauge of the brachial artery as a result of post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events. Several recent studies have shown that passive smoking is correlated with endothelial dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to smoking in non-smoking subjects, as part of a prospective study and controlled, has never been evaluated.


Eligibility criteria: Inclusion Criteria:

* Subject exposed at least one hour per day to passive smoking at work during at 1 year minimum for intervention arm and non exposed to passive smoking for control group.
* Subject having signed informed consent
* Subject with social security insurance or equivalent

Exclusion Criteria:

* Exposition to passive smoking at home
* Active smokers (at least 1 cigarette per day or having drawn up active smoking for less than a month)
* Medical history of homozygote familial hypercholesterolemia
* Usage of lipid lowering treatment in the month before the inclusion
* Hepatic active pathology or hepatocellular insufficiency
* Severe kidney disease (with creatine clearance less than 30 ml per minute)
* Evolutive cancer
* Usage of concomitant treatment as : insulin, nitro-derivatives and statins
* Medical history of alcoholism or drug use last year
* Medical history of permanent systolic hypotension (systolic blood pressure less than 90 mmHg) or non controled hypertension (systolic blood pressure higher than 200 mmHg and diastolic blood pressure 110 mmHg)
* Active cardiovascular disease
* Psychological or medical conditions incompatible with the study according to investigator opinion
* Participation to another study with experimental product or subject having received an study treatment within 4 weeks before inclusion
* Impossibility to follow the study procedure
* Pregnancy and breastfeeding
* Subject protected by french law

Primary outcomes:
measure: Comparison of Endothelial function between two groups of non smoking workers exposed or not to passive smoking at work before and after interdiction of smoking decree as assessed by mean change in dilatation percentage of brachial artery.
timeFrame: change between Day 0 and Day 90
Secondary outcomes:
measure: Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.
timeFrame: change between Day 0 and Day 90
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Alessandra BURA-RIVIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: