Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (DILATER)
17 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Toulouse, Francia, 65360
- Toulouse, Rangueil Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.
Periodo de tiempo: change between Day 0 and Day 90
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change between Day 0 and Day 90
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Alessandra BURA-RIVIERE, MD, University Hospital, Toulouse
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de diciembre de 2007
Finalización primaria (Actual)
30 de junio de 2008
Finalización del estudio (Actual)
30 de junio de 2008
Fechas de registro del estudio
Enviado por primera vez
9 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2016
Publicado por primera vez (Estimado)
20 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 07 269 03
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .