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A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol.

Published version
Peer-reviewed

Repository DOI


Change log

Authors

Krysiński, Arkadiusz  ORCID logo  https://orcid.org/0000-0002-4561-9574
Russo, Cristina 
Campagna, Davide 
Di Pino, Antonino 
John, Sarah 

Abstract

Stopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences.

Description

Funder: Eclat Srl; Grant(s): Award num: ECLAT CoE1-05

Keywords

Cardiovascular risk factors, Diabetes, Glycemic control, Heated tobacco products, Metabolic syndrome, Smoking cessation, Tobacco harm reduction, e-Cigarettes, Humans, Cardiovascular Diseases, Cigarette Smoking, Diabetes Mellitus, Type 2, Electronic Nicotine Delivery Systems, Heart Disease Risk Factors, Metabolic Syndrome, Multicenter Studies as Topic, Nicotine, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Smoking Cessation

Journal Title

Intern Emerg Med

Conference Name

Journal ISSN

1828-0447
1970-9366

Volume Title

19

Publisher

Springer Science and Business Media LLC
Sponsorship
Università di Catania (CRUI-CARE Agreement)