Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (DILATER)
2026年7月17日 更新者：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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
49
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Toulouse、法国、65360
- Toulouse, Rangueil Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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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其他：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：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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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.
大体时间：change between Day 0 and Day 90
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change between Day 0 and Day 90
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alessandra BURA-RIVIERE, MD、University Hospital, Toulouse
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年12月11日
初级完成 (实际的)
2008年6月30日
研究完成 (实际的)
2008年6月30日
研究注册日期
首次提交
2016年3月9日
首先提交符合 QC 标准的
2016年5月17日
首次发布 (估计的)
2016年5月20日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.