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.
⁃ 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.
• 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.