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
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2024-05-24 11:00
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KRYSINSKI, Arkadiusz, RUSSO, Cristina, CAMPAGNA, Davide, DI PINO, Antonino, JOHN, Sarah, BELSEY, Jonathan D., CAPONNETTO, Pasquale, VUDU, Lorina, LIM, Chong Wei, DI CIAULA, Agostino D.I., VERONESE, Nicola, BARBAGALLO, Mario, NOI, Autori. 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. In: Internal and Emergency Medicine, 2024, vol. 9, pp. 321-332. ISSN 1828-0447. DOI: https://doi.org/10.1007/s11739-023-03467-6
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Internal and Emergency Medicine
Volumul 9 / 2024 / ISSN 1828-0447 /ISSNe 1970-9366

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

DOI:https://doi.org/10.1007/s11739-023-03467-6

Pag. 321-332

Krysinski Arkadiusz1, Russo Cristina2, Campagna Davide3, Di Pino Antonino3, John Sarah4, Belsey Jonathan D.5, Caponnetto Pasquale3, Vudu Lorina6, Lim Chong Wei2, Di Ciaula Agostino D.I.7, Veronese Nicola8, Barbagallo Mario8, Noi Autori
 
1 Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw,
2 Ashford and Saint Peter's Hospitals Nhs Trust, Chertsey, Surrey,
3 University of Catania,
4 Universitatea Cambridge,
5 Jb Medical Ltd, Sudbury, Suffolk,
6 ”Nicolae Testemițanu” State University of Medicine and Pharmacy,
7 University of Bari Aldo Moro,
8 University of Palermo
 
 
Disponibil în IBN: 16 mai 2024


Rezumat

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. 

Cuvinte-cheie
cardiovascular diseases, Cigarette Smoking, diabetes mellitus, Type 2, Electronic Nicotine Delivery Systems, Heart Disease Risk Factors, Humans, metabolic syndrome, Multicenter Studies as Topic, Nicotiana, nicotine, Prospective Studies, Randomized Controlled Trials as Topic, risk factors, smoking cessation