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Completed

NCT Number: NCT02779127

Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse, Rangueil Hospital

Toulouse, 65360, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical interrogatory

Other

Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated

Medical examination

Other

Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation

Specific bioassay

Other

Exhaled carbon monoxide measure and nicotine in the urine are evaluated

Endothelial function evaluation

Other

Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation

General bioassay

Other

Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.

Primary outcomes

  1. 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.

    Time frame: change between Day 0 and Day 90

    Percentage of dilation of the brachial artery after test ischemia will be compared at the start and at the end of the study (Day 90)

Secondary outcomes

  1. Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.

    Time frame: change between Day 0 and Day 90

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: DILATER

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 20, 2016
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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