An interventional study of TOBACCO CIGARETTES and COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) in Cardiovascular Risk Factor and Diabetes Mellitus, Type 2, sponsored by Eclat Srl.. Recruiting at 1 site in United Kingdom. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Eclat Srl. · Not applicable, Interventional, and Health services research
Very little is known about the impact of combustion-free nicotine delivery systems (C-F NDS) on cardiovascular risk factors in T2DM patients who smoke. Data from clinical studies to identify any potential reduction in individuals' risk, relative to the risk of continued smoking, are needed.
This study aims to test the hypothesis that avoiding exposure to cigarette smoke toxicants may translate to measurable improvement in cardiovascular risk factors and functional parameters when T2DM patients who smoke switch to using C-F NDS compared with T2DM patients who continue to smoke conventional tobacco products.
The investigators propose a prospective 2-year multicenter randomized controlled trial (RCT) to evaluate changes in cardiovascular risk factors and functional parameters in diabetic smokers using C-F NDS and compared to those continuing cigarette smoking.
This is a multicenter, controlled study utilizing a randomized switching design for cigarette smoking and C-F NDS use. The study will take place in one site in each of five countries. Three countries have so far agreed to participate: UK, Italy, Poland. An amendment will be submitted to the REC once the final two countries are signed up.
A volunteer population of adult smokers with T2DM will be recruited. Smokers will be randomized (1:2 ratio) to either continue to smoke their own cigarette brand (Study Arm A) or use C-F NDS (Study Arm B). The intended minimum number of participants in each arm by the end of the study is 147.
Before randomization, all smokers will be reminded of the risks associated with smoking and will be offered a free smoking cessation program according to standard local guidelines and depending on the local availability of antismoking services. Those who decline the invitation will be eligible for recruitment into the RCT.
Smokers are free to voluntarily quit smoking/C-F NDS and/or withdraw from the study at any time.
Duration:
This will be a prospective 2-year study conducted in the ambulatory setting. Participants will attend a total of 5 clinic visits at Screening, Day 1 (Visit 1), Day 90 (+/-5 days) (Visit 2), Day 180 (+/-7 days) (Visit 3), Day 360 (+/-7 days) (Visit 4), and Day 720 (+/-7 days) (Visit 5).
Participants will undergo screening within 28 days prior to Day 1. Eligible participants will be enrolled and randomized on Day 1.
Study Arms and Randomization Plan Participants who were eligible and consent to take part will be randomized to either continuing smoking their own cigarette brand (Arm A) or switching to using C-F NDS (Arm B).
The randomization sequence will be computer generated, with an allocation ratio of 1:2 (Arm A: Arm B) to compensate for an estimated 50% success rate (defined as combined smoking abstinence rate + >80% smoking reduction rate) in the long term (more details in the section about Sample Size Calculation). The randomization scheme will be provided to clinical sites via a web-based application set up by the CRO. The staff randomizing the participant will access the web-based application when the participant is with them, entering their participant identification number, date of birth and initials into the program. The allocation will be immediately provided by the program/software.
Product Use Smokers will continue to smoke their usual brand of cigarette until randomization on Day 1. After randomization, participants in Arms A and B will be asked to use only their assigned products ad libitum for the whole duration of the study (for more info/details - see below).
Participants in Arm A will continue smoking their own cigarette brand as usual. Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counseled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4, 10 ml refill containers). Free products will be supplied at each subsequent visit throughout the whole duration of the study
Product Monitoring and Compliance A prospective evaluation of cigarette consumption will be carried out throughout the study (see below). Cigarette use will be self-reported and recorded in the eCRF/ automated eDiary-SMS system (+ APP tracker).
Participants in Arm B will be instructed on the importance of using exclusively their C-F NDS and to abstain from smoking. Participants will be asked to report any non-compliance via the automated eDiary-SMS system (+ APP tracker), and will be informed that compliance assessments will be conducted throughout the study. Non-compliance will be documented.
Justification for Study Design
Participants in this study will be a minimum of 23 years of age. This is based on:
Treatment blinding This is an unblinded study. It will not be possible to blind participants to the intervention they will be receiving. It will not be possible to blind trial staff when providing the interventions and collecting data.
Unblinded data will be seen and analysed by the Trial Statistician for the purposes of the Data Monitoring and Ethics Committee (DMEC) meetings. All other trial staff who has access to outcome data will remain blinded until prespecified data analyses will be completed. Prespecified data analyses will be conducted blind to treatment allocation.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 576 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eclat Srl. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be required to satisfy all of the following criteria at the screening visit, unless otherwise stated:
Exclusion Criteria:
Participants will be excluded at the screening visit based on the following criteria:
At screening and prior to enrolment, all patients will be offered a locally available free smoking cessation program as per local guidelines. Those who express the intention of booking for the cessation program together with those who, at screening, are planning to quit smoking in the next 6 months, will not be recruited in the study. Patients taking part in the study will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to local stop smoking services.
Withdrawal Criteria:
Patients may be withdrawn from the study prematurely for the following reasons:
If any deviations occur during the conduct of the study, which cannot be corrected. All protocol deviations will be fully documented and considered for their effect on study objectives. Deviations that could lead to subject discontinuation from the study include:
Participant continues smoking their own cigarette brand.
Other: TOBACCO CIGARETTES
Participant switches to using C-F NDS
Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
Participants in Arm A will continue smoking their own cigarette brand as usual.
Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counselled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device (HTD) will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4 x 10 ml refill containers).
Change in Metabolic Syndrome Prevalence
Percentage (%) change in Metabolic Syndrome Prevalence
Time frame: Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Change in Plasma Glucose
Change in plasma glucose (mmol/L) will be measured from baseline at different study time-points
Time frame: Change in plasma glucose from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Change in Blood Pressure
Change in blood pressure (mmHg) will be measure from baseline at different study time-points
Time frame: Change in blood pressure from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Change in Triglycerides
Change in triglycerides (mmol/L) will be measured from baseline at different study time-points
Time frame: Change in triglycerides from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Change in High-Density Lipoprotein (HDL)
Change in HDL (mmol/L) will be measured from baseline at different study time-points
Time frame: Change in HDL from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Change in Waist Circumference
Change in waist circumference (cm) will be measured from baseline at different study time-points
Time frame: Change in waist circumference from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years
Plan to share: No
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