The ESTxENDS Trial- Substudy on the Metabolic Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)
- Conditions
- Cardiovascular DiseasesSmoking Cessation
- Interventions
- Other: ENDS (vaporizer/e-cig) and smoking cessation counselingOther: Smoking cessation counseling
- Registration Number
- NCT03612336
- Lead Sponsor
- University of Bern
- Brief Summary
--\> This is a substudy of the main ESTxENDS trial (NCT03589989). Metabolic outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Cardiovascular diseases (CVD) are a leading cause of death in cigarette smokers; quitting smoking is associated with reduced CVD. Cigarette smoking increases CVD through complex mechanisms, mostly on an increase in atherosclerosis and the effect appears unrelated to nicotine. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking. There is currently no evidence that ENDS use affects CVD outcomes. The nicotine contained in the e-liquids from ENDS has cardiovascular effects and the evidence about health effects mostly comes from studies on nicotine replacement therapy (NRT). These studies did not show an increased risk of CVD from NRTs. The ECLAT trial showed no difference in body weight, resting heart rate, or blood pressure between those who used ENDS or not. Two studies evaluated the short-term effects of ENDS on the cardiovascular system. One study suggested impairment in diastolic ventricular function with cigarettes and not with ENDS. Both ENDS and cigarettes increased diastolic blood pressure, potentially mediated through nicotine exposure, but an increased systolic blood pressure was found only in cigarette smokers. Other studies have suggested no changes in blood pressure in daily users of electronic cigarettes up to 1 year with some even a reduction in blood pressure among patients with hypertension. Interventions helping smokers quit have shown that quitting is associated with increased HDL-cholesterol, weight gain, higher blood glucose, and higher diabetes risk. No large randomized trials have tested the effect of ENDS on blood cholesterol and other markers of cardiovascular risk.
This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals.
For the main ESTxENDS trial (NCT03589989), smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measurements of risk factors for cardiovascular diseases will be done at baseline and at 6, 12 and 24 months' follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1246
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group ENDS (vaporizer/e-cig) and smoking cessation counseling - Control group Smoking cessation counseling -
- Primary Outcome Measures
Name Time Method Measurements of risk factors for cardiovascular diseases (heart rate)_1 6 months post quit date Measurement of heart rate
Measurements of risk factors for cardiovascular diseases (total cholesterol)_1 6 months post quit date Measurement of total cholesterol
Measurements of risk factors for cardiovascular diseases (blood pressure)_1 6 months post quit date Measurement of blood pressure
Measurements of risk factors for cardiovascular diseases (blood pressure)_2 12 months post quit date Measurement of blood pressure
Measurements of risk factors for cardiovascular diseases (heart rate)_2 12 months post quit date Measurement of heart rate
Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_2 12 months post quit date Measurement of LDL-cholesterol
Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_3 24 months post quit date Measurement of LDL-cholesterol
Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_2 12 months post quit date Measurement of HDL-cholesterol
Measurements of risk factors for cardiovascular diseases (blood pressure)_3 24 months post quit date Measurement of blood pressure
Measurements of risk factors for cardiovascular diseases (heart rate)_3 24 months post quit date Measurement of heart rate
Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_1 6 months post quit date Measurement of HDL-cholesterol
Measurements of risk factors for cardiovascular diseases (creatinine)_1 6 months post quit date Measurement of creatinine
Measurements of risk factors for cardiovascular diseases (creatinine)_2 12 months post quit date Measurement of creatinine
Measurements of risk factors for cardiovascular diseases (waist circumference)_1 6 months post quit date Measurement of waist circumference
Measurements of risk factors for cardiovascular diseases (triglycerides)_1 6 months post quit date Measurement of triglycerides
Measurements of risk factors for cardiovascular diseases (total cholesterol)_2 12 months post quit date Measurement of total cholesterol
Measurements of risk factors for cardiovascular diseases (total cholesterol)_3 24 months post quit date Measurement of total cholesterol
Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_1 6 months post quit date Measurement of LDL-cholesterol
Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_3 24 months post quit date Measurement of HDL-cholesterol
Measurements of risk factors for cardiovascular diseases (triglycerides)_2 12 months post quit date Measurement of triglycerides
Measurements of risk factors for cardiovascular diseases (triglycerides)_3 24 months post quit date Measurement of triglycerides
Measurements of risk factors for cardiovascular diseases (HbA1c)_1 6 months post quit date Measurement of HbA1c for persons with diagnosed diabetes
Measurements of risk factors for cardiovascular diseases (HbA1c)_2 12 months post quit date Measurement of HbA1c for persons with diagnosed diabetes
Measurements of risk factors for cardiovascular diseases (HbA1c)_3 24 months post quit date Measurement of HbA1c for persons with diagnosed diabetes
Measurements of risk factors for cardiovascular diseases (creatinine)_3 24 months post quit date Measurement of creatinine
Measurements of risk factors for cardiovascular diseases (waist circumference)_3 24 months post quit date Measurement of waist circumference
Measurements of risk factors for cardiovascular diseases (waist circumference)_2 12 months post quit date Measurement of waist circumference
Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_1 6 months post quit date Measurements of weight and height to report BMI in kg/m\^2
Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_2 12 months post quit date Measurements of weight and height to report BMI in kg/m\^2
Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_3 24 months post quit date Measurements of weight and height to report BMI in kg/m\^2
- Secondary Outcome Measures
Name Time Method Changes in cardiovascular disease risk factors (blood pressure) Change from Baseline to 6,12, 24 months post quit date Measurement of blood pressure
Changes in cardiovascular disease risk factors (total cholesterol) Change from Baseline to 6,12, 24 months post quit date Measurement of total cholesterol
Physical activity 6,12, 24 months post quit date Measured using the International Physical activity questionnaire (IPAQ). The short version (7 items) provides information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity.
Changes of physical activity Change from Baseline to 6,12, 24 months post quit date Measured using the International Physical activity questionnaire (IPAQ). The short version (7 items) provides information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity.
Changes in cardiovascular disease risk factors (triglycerides) Change from Baseline to 6,12, 24 months post quit date Measurement of triglycerides
Changes in cardiovascular disease risk factors (heart rate) Change from Baseline to 6,12, 24 months post quit date Measurement of heart rate
Changes in cardiovascular disease risk factors (HDL- cholesterol) Change from Baseline to 6,12, 24 months post quit date Measurement of HDL- cholesterol
Changes in cardiovascular disease risk factors (creatinine) Change from Baseline to 6,12, 24 months post quit date Measurement of creatinine
Changes in cardiovascular disease risk factors (LDL-cholesterol) Change from Baseline to 6,12, 24 months post quit date Measurement of LDL-cholesterol
Changes in cardiovascular disease risk factors (waist circumference) Change from Baseline to 6,12, 24 months post quit date Measurement of waist circumference
Changes in cardiovascular disease risk factors (body mass index, BMI) Change from Baseline to 6,12, 24 months post quit date Measurements of weight and height to report BMI in kg/m\^2
Changes in cardiovascular disease risk factors (HbA1c) Change from Baseline to 6,12, 24 months post quit date Measurement of HbA1c for persons with diagnosed diabetes
Trial Locations
- Locations (5)
Département de médecine interne, Hôpitaux universitaires de Genève
🇨ðŸ‡Geneva, Switzerland
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
🇨ðŸ‡Zürich, Switzerland
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
🇨ðŸ‡Saint Gallen, Switzerland
University Clinic for General Internal Medicine, Bern University Hospital
🇨ðŸ‡Bern, Switzerland
Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
🇨ðŸ‡Lausanne, Vaud, Switzerland