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

T

Toulouse University Hospital

Status

Completed

Conditions

Smoking

Treatments

Other: Endothelial function evaluation
Other: Specific bioassay
Other: General bioassay
Other: Medical examination
Other: Medical interrogatory

Study type

Interventional

Funder types

Other

Identifiers

NCT02779127
07 269 03

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Intervention
Other group
Description:
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
Treatment:
Other: General bioassay
Other: Endothelial function evaluation
Other: Specific bioassay
Other: Medical interrogatory
Other: Medical examination
Control
Other group
Description:
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
Treatment:
Other: General bioassay
Other: Endothelial function evaluation
Other: Specific bioassay
Other: Medical interrogatory
Other: Medical examination

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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