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

Smoking Clinical Trial

— DILATER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779127
• Other study ID #: 07 269 03
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: April 14, 2017
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: April 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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