SmokingDILATERNCT02779127
Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers
A study testing Medical interrogatory, Medical examination and Specific bioassay in people with Smoking, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Medical interrogatory, Medical examination and Specific bioassay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2007to 30 Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Smoking
- Being tested
- Medical interrogatory, Medical examination, Specific bioassay, Endothelial function evaluation, General bioassay
- Keywords
- Smoking, Endothelium, Passive smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical interrogatoryOther
Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
Medical examinationOther
Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
Specific bioassayOther
Exhaled carbon monoxide measure and nicotine in the urine are evaluated
Endothelial function evaluationOther
Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
General bioassayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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 Receives: Other: Medical interrogatory; Other: Medical examination; Other: Specific bioassay; Other: Endothelial function evaluation; Other: General bioassay |
| Control | Other | 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 Receives: Other: Medical interrogatory; Other: Medical examination; Other: Specific bioassay; Other: Endothelial function evaluation; Other: General bioassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change between Day 0 and 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.
Measured: change between Day 0 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start11 Dec 2007
- Primary completion30 Jun 2008
- Study completion30 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra BURA-RIVIERE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779127
- Sponsor's protocol ID
- 07 269 03
- Acronym
- DILATER
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2016
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02779127
- Acronym / sponsor ID
- DILATER / 07 269 03
- Conditions
- Smoking
- Keywords
- Smoking, Endothelium, Passive smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 11 Dec 2007 (actual)
- Primary completion
- 30 Jun 2008 (actual)
- Study completion
- 30 Jun 2008 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Medical interrogatory, Other: Medical examination, Other: Specific bioassay, Other: Endothelial function evaluation, Other: General bioassaySubjects 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 |
| Control | Other | Other: Medical interrogatory, Other: Medical examination, Other: Specific bioassay, Other: Endothelial function evaluation, Other: General bioassaySubjects 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical interrogatoryCardiovascular risk, medical history, known pathologies and actual treatments are evaluated | Other | Control, Intervention |
| Medical examinationSystolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation | Other | Control, Intervention |
| Specific bioassayExhaled carbon monoxide measure and nicotine in the urine are evaluated | Other | Control, Intervention |
| Endothelial function evaluationEndothelial function evaluation done by echotracking determining the basale flow mediated dilatation | Other | Control, Intervention |
| General bioassayFasting 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, Intervention |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra BURA-RIVIERE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical interrogatory, Medical examination and Specific bioassay in people with Smoking, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.