Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (DILATER)
17 juli 2026 uppdaterad av: University Hospital, Toulouse
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
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
49
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Toulouse, Frankrike, 65360
- Toulouse, Rangueil Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation |
Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
Exhaled carbon monoxide measure and nicotine in the urine are evaluated
Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
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.
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Övrig: Control
Subjects non expose to passive smoking at home or at work, non active smokers Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation |
Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
Exhaled carbon monoxide measure and nicotine in the urine are evaluated
Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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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.
Tidsram: change between Day 0 and Day 90
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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)
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change between Day 0 and Day 90
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.
Tidsram: change between Day 0 and Day 90
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change between Day 0 and Day 90
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Alessandra BURA-RIVIERE, MD, University Hospital, Toulouse
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 december 2007
Primärt slutförande (Faktisk)
30 juni 2008
Avslutad studie (Faktisk)
30 juni 2008
Studieregistreringsdatum
Först inskickad
9 mars 2016
Först inskickad som uppfyllde QC-kriterierna
17 maj 2016
Första postat (Beräknad)
20 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 07 269 03
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .