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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Medical interrogatory; Other: Medical examination; Other: Specific bioassay; Other: Endothelial function evaluation; Other: General bioassay

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Medical interrogatory; Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated; Other: Medical examination; Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation; Other: Specific bioassay; Exhaled carbon monoxide measure and nicotine in the urine are evaluated; Other: Endothelial function evaluation; Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation; Other: General bioassay; 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.
Other: 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	Other: Medical interrogatory; Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated; Other: Medical examination; Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation; Other: Specific bioassay; Exhaled carbon monoxide measure and nicotine in the urine are evaluated; Other: Endothelial function evaluation; Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation; Other: General bioassay; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	change between Day 0 and Day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.	change between Day 0 and Day 90

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Alessandra BURA-RIVIERE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Smoking; Endothelium; Passive smoking
• Other Study ID Numbers: 07 269 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No