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Cardiovascular Risk FactorDIASMOKENCT04231838

Metabolic Syndrome in Diabetic Smokers Using Cigarettes & Combustion-Free Nicotine Delivery Systems

A study testing TOBACCO CIGARETTES and COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) in people with Cardiovascular Risk Factor and Diabetes Mellitus, Type 2, run by Eclat Srl. at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 23 years and older
What is being tested?
TOBACCO CIGARETTES and COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
1 siteUnited Kingdom
Study dates
27 Sep 2021to 31 Mar 2026
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 23 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants will be required to satisfy all of the following criteria at the screening visit, unless otherwise stated:
  • Participants will be: 1.1. over 23 years of age
  • T2DM Patients will have: 2.1. body mass index (BMI) between 17.6 and 34.5 kg/m2, inclusive 2.2. body weight exceeding 50 kg (males) or 40 kg (females) 2.3 6.0<HbA1C<12 3.2. completion of proforma (CRF) 3.3. lab assessment as outlined in the CRF
  • Participants will be willing to refrain from eating/drinking prior to screening and Check-in at each study visit.
  • Participants will be regular smokers of at least 10 cigarettes/day (max 30 cigarette/day)
  • Participants will have smoked for at least five consecutive years prior to screening.
Show all 9Show fewer
  • Participants must have a saliva cotinine level > 10 ng/mL or an exhaled breath CO (eCO) level > 7 ppm at screening.
  • Participants in Arm A who continue to smoke will be willing to use their own brand/type cigarettes.
  • Participants in Arms B will be willing to use the study products (THP product or e-cigarette) provided to them during the study.

Who cannot join

  • Participants will be excluded at the screening visit based on the following criteria:
  • Female participants who are pregnant or breastfeeding. This will be confirmed at screening and at visit 1. Any female subject who becomes pregnant during this study will be withdrawn.
  • Participants with a history of recent acute decompensation of their disease requiring treatment within 4 weeks prior to visit 1.
  • Participants who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the investigator.
  • Participants who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first product use.
  • Participants who have, or who have a history of, any clinically-significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results.
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  • Participants who regularly use any nicotine (e.g. e-cigarettes, NRT) or tobacco product (e.g. HTPs, oral smokeless) other than their own cigarettes within 14 days of screening.
  • 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:
  • subject experiences a severe adverse event (SAE). The appropriate SAE electronic Case Report Form (eCRF) page must be completed.
  • 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:
  • deviations which could affect subject's safety (e.g. illness requiring treatment[s]) which in the clinical judgement of the investigator might invalidate the study by interfering with the allocated test product or the willingness of the subject to comply with the study activities.
  • deviations involving the use of any nicotine/tobacco products other than the intended conventional cigarettes (in Arm A) or (in Arm B).
  • If the subject is uncooperative, including non-attendance. In these cases, efforts should have been made by the investigator to ascertain the reason and to ensure the subject's attendance as soon as possible.
  • Subject's personal request: the subject could decide, at any moment of the study, to stop his/her participation.
  • Female participant becoming pregnant.

Trial locations and contacts

1 site in 1 country.

Daniela Saitta, PhD contact

00390954781124

daniela.saitta@eclatrbc.it

Riccardo Polosa, PhD contact

00390953781566

polosa@unict.it

United Kingdom1 site, 1 recruiting

  • Ashford and St Peters NHS Foundation Trust

    Chertsey, Surrey, KT16 0PZ

    Chong W Lim, PhD, 0044 1932726196, Chong.Lim@nhs.net

    Freda Gomes, MSc, +44 193 272 3534, Freda.Gomes@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study

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.

Read the detailed description

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:

  • The legal age to obtain tobacco products is 18 years
  • Participants will be required to have a smoking history of at least 5 years To investigate the effects of abstaining from smoking by switching in smokers with T2DM, a population of patients who are intending to make the switch to N-C NDS will be recruited. By the end of the study, it is estimated that a high proportion (approx. 50%) of patients randomized in the Arm B of the study will not be able to achieve success (defined as either complete smoking abstinence or as at least 80% smoking reduction). To account for this, the C-F NDS population will be oversampled and a 1:2 randomization ratio scheme (i.e. for every patient randomized in the continue-to-smoke population, two will be randomized in the C-F NDS population) will be adopted.

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.

Being tested
TOBACCO CIGARETTES, COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
Keywords
e-cigarettes, Combustion-Free Nicotine Delivery Systems, Diabetes Mellitus, Type 2, Cardiovascular Risk Factor, Tobacco Cigarettes, DIASMOKE 2.0, Metabolic syndrome
Medical subject headings
Diabetes Mellitus, Type 2, Vaping, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOBACCO CIGARETTESOther

    Participants in Arm A will continue smoking their own cigarette brand as usual.

  • COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)Other

    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).

Study groups in NCT04231838
Study groupRoleWhat they receive
Standard Arm (Arm A)Active comparatorParticipant continues smoking their own cigarette brand.
Receives: Other: TOBACCO CIGARETTES
Intervention Arm (Arm B)Active comparatorParticipant switches to using C-F NDS
Receives: Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Metabolic Syndrome Prevalence

    Percentage (%) change in Metabolic Syndrome Prevalence

    Measured: Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

Secondary outcomes (5)

  1. Change in Plasma Glucose

    Change in plasma glucose (mmol/L) will be measured from baseline at different study time-points

    Measured: Change in plasma glucose from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

  2. Change in Blood Pressure

    Change in blood pressure (mmHg) will be measure from baseline at different study time-points

    Measured: Change in blood pressure from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

  3. Change in Triglycerides

    Change in triglycerides (mmol/L) will be measured from baseline at different study time-points

    Measured: Change in triglycerides from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

  4. Change in High-Density Lipoprotein (HDL)

    Change in HDL (mmol/L) will be measured from baseline at different study time-points

    Measured: Change in HDL from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

  5. Change in Waist Circumference

    Change in waist circumference (cm) will be measured from baseline at different study time-points

    Measured: Change in waist circumference from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start27 Sep 2021
  3. Primary completion16 Sep 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
576 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04231838
Sponsor's protocol ID
COE1-05-DIASMOKE 2.0
Acronym
DIASMOKE
Status last verified
Oct 2022
First submitted
11 Dec 2019
Last updated
27 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fowler MJ. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes. 2011;29:116-22.

  • Pan A, Wang Y, Talaei M, Hu FB, Wu T. Relation of active, passive, and quitting smoking with incident type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Dec;3(12):958-67. doi: 10.1016/S2213-8587(15)00316-2. Epub 2015 Sep 18.

    PubMed 26388413

  • Wei M, Gaskill SP, Haffner SM, Stern MP. Effects of diabetes and level of glycemia on all-cause and cardiovascular mortality. The San Antonio Heart Study. Diabetes Care. 1998 Jul;21(7):1167-72. doi: 10.2337/diacare.21.7.1167.

    PubMed 9653614

  • Al-Delaimy WK, Manson JE, Solomon CG, Kawachi I, Stampfer MJ, Willett WC, Hu FB. Smoking and risk of coronary heart disease among women with type 2 diabetes mellitus. Arch Intern Med. 2002 Feb 11;162(3):273-9. doi: 10.1001/archinte.162.3.273.

    PubMed 11822919

  • Chuahirun T, Simoni J, Hudson C, Seipel T, Khanna A, Harrist RB, Wesson DE. Cigarette smoking exacerbates and its cessation ameliorates renal injury in type 2 diabetes. Am J Med Sci. 2004 Feb;327(2):57-67. doi: 10.1097/00000441-200402000-00001.

    PubMed 14770020

  • Qin R, Chen T, Lou Q, Yu D. Excess risk of mortality and cardiovascular events associated with smoking among patients with diabetes: meta-analysis of observational prospective studies. Int J Cardiol. 2013 Jul 31;167(2):342-50. doi: 10.1016/j.ijcard.2011.12.100. Epub 2012 Jan 16.

    PubMed 22251416

  • Pan A, Wang Y, Talaei M, Hu FB. Relation of Smoking With Total Mortality and Cardiovascular Events Among Patients With Diabetes Mellitus: A Meta-Analysis and Systematic Review. Circulation. 2015 Nov 10;132(19):1795-804. doi: 10.1161/CIRCULATIONAHA.115.017926. Epub 2015 Aug 26.

    PubMed 26311724

  • Cacciola RR, Guarino F, Polosa R. Relevance of endothelial-haemostatic dysfunction in cigarette smoking. Curr Med Chem. 2007;14(17):1887-92. doi: 10.2174/092986707781058832.

    PubMed 17627524

  • Stanton CA, Keith DR, Gaalema DE, Bunn JY, Doogan NJ, Redner R, Kurti AN, Roberts ME, Higgins ST. Trends in tobacco use among US adults with chronic health conditions: National Survey on Drug Use and Health 2005-2013. Prev Med. 2016 Nov;92:160-168. doi: 10.1016/j.ypmed.2016.04.008. Epub 2016 Apr 15.

    PubMed 27090919

  • Ford ES, Mokdad AH, Gregg EW. Trends in cigarette smoking among US adults with diabetes: findings from the Behavioral Risk Factor Surveillance System. Prev Med. 2004 Dec;39(6):1238-42. doi: 10.1016/j.ypmed.2004.04.039.

    PubMed 15539062

  • Caponnetto P, Russo C, Polosa R. Smoking cessation: present status and future perspectives. Curr Opin Pharmacol. 2012 Jun;12(3):229-37. doi: 10.1016/j.coph.2012.02.005. Epub 2012 Mar 5.

    PubMed 22398322

  • Polosa R, Benowitz NL. Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci. 2011 May;32(5):281-9. doi: 10.1016/j.tips.2010.12.008. Epub 2011 Jan 20.

    PubMed 21256603

  • Nagrebetsky A, Brettell R, Roberts N, Farmer A. Smoking cessation in adults with diabetes: a systematic review and meta-analysis of data from randomised controlled trials. BMJ Open. 2014 Mar 6;4(3):e004107. doi: 10.1136/bmjopen-2013-004107.

    PubMed 24604481

  • Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10:19. doi: 10.1186/1477-7517-10-19.

    PubMed 24090432

  • Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430.

    PubMed 25083263

Questions about this trial

What is this clinical trial studying?

A study testing TOBACCO CIGARETTES and COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) in people with Cardiovascular Risk Factor and Diabetes Mellitus, Type 2, run by Eclat Srl. at 1 site in United Kingdom.

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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 United Kingdom. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniela Saitta, PhD (00390954781124, daniela.saitta@eclatrbc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231838, which also lists 39 linked publications.

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 27 Oct 2022.

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