DIASMOKE Study

• Research type

  Research Study

• Full 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

• IRAS ID

  280909

• Contact name

  Daniela Saitta

• Contact email

  daniela.saitta@unict.it

• Sponsor organisation

  ECLAT Srl.

• Clinicaltrials.gov Identifier

  NCT04231838

• Duration of Study in the UK

  4 years, 0 months, 1 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 international multicentre randomized controlled trial (RCT) to evaluate changes in metabolic syndrome in diabetic smokers using C-F NDS and compared to those continuing cigarette smoking.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  20/LO/0704

• Date of REC Opinion

  22 May 2020

• REC opinion

  Favourable Opinion