DIASMOKE 2.0 Study

• Research type

  Research Study

• Full title

  A Randomised Controlled Multicentre Study evaluating changes in Cardiovascular Risk Factors in Smokers with type 2 Diabetes Mellitus after switching from Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE 2.0 Study

• IRAS ID

  275176

• Contact name

  Daniela Saitta

• Contact email

  daniela.saitta@unict.it

• Sponsor organisation

  ECLAT Srl.

• Duration of Study in the UK

  3 years, 9 months, 28 days

• Research 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.
  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.
  We 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.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  20/SC/0030

• Date of REC Opinion

  30 Jan 2020

• REC opinion

  Unfavourable Opinion