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Open Access 24-11-2023 | Combustion | IM - ORIGINAL

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

Authors: Arkadiusz Krysiński, Cristina Russo, Davide Campagna, Antonino Di Pino, Sarah John, Jonathan Belsey, Pasquale Caponnetto, Lorina Vudu, Chong Wei Lim, Agostino Di Ciaula, Nicola Veronese, Mario Barbagallo, Farrukh Iqbal, David Fluck, Edward Franek, Riccardo Polosa, Pankaj Sharma, the DiaSmokeFree investigators

Published in: Internal and Emergency Medicine | Issue 2/2024

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.

GBD Diseases and Injuries Collaborators (2020) Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet 17(396(10258)):1204–1222. https://doi.org/10.1016/S0140-6736(20)30925-9CrossRef

Fowler MJ (2011) Microvascular and macrovascular complications of diabetes. Clin Diabetes 29:116–122CrossRef

Pan A, Wang Y, Talaei M, Hu FB (2015) Relation of smoking with total mortality and cardiovascular events among patients with diabetes mellitus: a meta-analysis and systematic review. Circulation 132(19):1795–1804CrossRefPubMedPubMedCentral

Qin R, Chen T, Lou Q et al (2013) Excess risk of mortality and cardiovascular events associated with smoking among patients with diabetes: meta-analysis of observational prospective studies. Int J Cardiol 167:342–350CrossRefPubMed

Campagna D, Alamo A, Di Pino A, Russo C, Calogero AE, Purrello F, Polosa R (2019) Smoking and diabetes: dangerous liaisons and confusing relationships. Diabetol Metab Syndr 24(11):85. https://doi.org/10.1186/s13098-019-0482-2CrossRef

Cacciola RR, Guarino F, Polosa R (2007) Relevance of endothelial-haemostatic dysfunction in cigarette smoking. Curr Med Chem 14:1887–1892CrossRefPubMed

Guarino F, Cantarella G, Caruso M, Russo C, Mancuso S, Arcidiacono G, Cacciola RR, Bernardini R, Polosa R (2011) Endothelial activation and injury by cigarette smoke exposure. J Biol Regul Homeost Agents 25(2):259–268 (PMID: 21880215)PubMed

Caponnetto P, Russo C, Di Maria A, Morjaria JB, Barton S, Guarino F, Basile E, Proiti M, Bertino G, Cacciola RR, Polosa R (2011) Circulating endothelial-coagulative activation markers after smoking cessation: a 12-month observational study. Eur J Clin Invest 41(6):616–626CrossRefPubMed

Stanton CA, Keith DR, Gaalema DE et al (2016) Trends in tobacco use among US adults with chronic health conditions: national survey on drug use and health 2005–2013. Prev Med 92:160–168CrossRefPubMedPubMedCentral

10.

Ford ES, Mokdad AH, Gregg EW (2004) Trends in cigarette smoking among US adults with diabetes: findings from the behavioral risk factor surveillance system. Prev Med 39:1238–1242CrossRefPubMed

11.

Fan AZ, Rock V, Zhang X, Li Y, Elam-Evans L, Balluz L (2013) Trends in cigarette smoking rates and quit attempts among adults with and without diagnosed diabetes, United States, 2001–2010. Prev Chronic Dis 19(10):120259CrossRef

12.

Polosa R, Benowitz NL (2011) Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci 32:281–289CrossRefPubMedPubMedCentral

13.

Stead LF, Koilpillai P, Fanshawe TR, Lancaster T (2016) Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Sys Rev. https://doi.org/10.1002/14651858.CD008286.pub3CrossRef

14.

United States public health service office of the surgeon general, national center for chronic disease prevention and health promotion (US) office on smoking and health. Smoking cessation: a report of the Surgeon General. US department of health and human services; 2020. https://www.ncbi.nlm.nih.gov/books/NBK555591/. Accessed 8 May 2023

15.

Rigotti NA, Kruse GR, Livingstone-Banks J, Hartmann-Boyce J (2022) Treatment of tobacco smoking: a review. JAMA 327(6):566–577. https://doi.org/10.1001/jama.2022.0395CrossRefPubMed

16.

Nagrebetsky A, Brettell R, Roberts N, Farmer A (2014) Smoking cessation in adults with diabetes: a systematic review and meta-analysis of data from randomised controlled trials. BMJ Open 4(3):e004107. https://doi.org/10.1136/bmjopen-2013-004107CrossRefPubMedPubMedCentral

17.

Russo C, Walicka M, Caponnetto P, Cibella F, Maglia M, Alamo A, Campagna D, Frittitta L, Di Mauro M, Caci G, Krysinski A, Franek E, Polosa R (2022) Efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: a randomized clinical trial. JAMA Netw Open 5(6):e2217709. https://doi.org/10.1001/jamanetworkopen.2022.17709CrossRefPubMedPubMedCentral

18.

O’Leary R, Polosa R (2020) Tobacco harm reduction in the 21st century. Drugs Alcohol Today 20(3):219–234. https://doi.org/10.1108/DAT-02-2020-0007CrossRef

19.

Caruso M, Emma R, Distefano A, Rust S, Poulas K, Giordano A, Volarevic V, Mesiakaris K, Boffo S, Arsenijevic A, Karanasios G, Pulvirenti R, Ilic A, Canciello A, Zuccarello P, Ferrante M, Polosa R, Li VG (2022) Comparative assessment of electronic nicotine delivery systems aerosol and cigarette smoke on endothelial cell migration: the replica project. Drug Test Anal. https://doi.org/10.1002/dta.3349CrossRefPubMed

20.

Morjaria JB, Campagna D, Caci G, O’Leary R, Polosa R (2022) Health impact of e-cigarettes and heated tobacco products in chronic obstructive pulmonary disease: current and emerging evidence. Expert Rev Respir Med 16(11–12):1213–1226. https://doi.org/10.1080/17476348.2023.2167716CrossRefPubMed

21.

Hartmann-Boyce J, Lindson N, Butler AR, McRobbie H, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Fanshawe TR, Hajek P (2022) Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev 11(11):CD010216. https://doi.org/10.1002/14651858.CD010216.pub7CrossRefPubMed

22.

Caponnetto P, Campagna D, Maglia M, Benfatto F, Emma R, Caruso M, Caci G, Busà B, Pennisi A, Ceracchi M, Migliore M, Signorelli M (2023) Comparing the effectiveness, tolerability, and acceptability of heated tobacco products and refillable electronic cigarettes for cigarette substitution (CEASEFIRE): randomized controlled trial. JMIR Public Health Surveill 4(9):e42628. https://doi.org/10.2196/42628CrossRef

23.

National Institute of Health (2001) Executive summary of the third report of the national cholesterol education program (NCEP) expert panel on detection, evaluation and treatment of high blood cholesterol in adults (Adult treatment panel III). JAMA 285:2486–2497CrossRef

24.

Didangelos TP, Thanopoulou AK, Bousboulas SH et al (2004) The ORLIstat and CArdiovascular risk profile in patients with metabolic syndrome and type 2 DIAbetes (ORLICARDIA) study. Curr Med Res Opin 20(9):1393–1401CrossRefPubMed

25.

Bo S, Ciccone G, Baldi C et al (2007) Effectiveness of a lifestyle intervention on metabolic syndrome. A randomized controlled trial. J Gen Intern Med 22(12):1695–1703CrossRefPubMedPubMedCentral

26.

Christensen P, Bliddal H, Riecke BF et al (2011) Comparison of a low-energy diet and a very low-energy diet in sedentary obese individuals: a pragmatic randomized controlled trial. Clin Obes 1(1):31–40CrossRefPubMed

27.

Yoon NH, Yoo S, Kim H et al (2015) Routine screening and consultation facilitate improvement of metabolic syndrome. J Korean Med Sci 30(8):1092–1100CrossRefPubMedPubMedCentral

28.

Sharip A, Firek A, Tonstad S (2017) The effects of smoking cessation on the risk factors for the metabolic syndrome: a follow-up study of veterans. J Smok Cessat 12(3):143–152CrossRef

29.

Bonadonna RC, Cucinotta D, Fedele D et al (2006) The metabolic syndrome is a risk indicator of microvascular and macrovascular complications in diabetes: results from Metascreen, a multicenter diabetes clinic-based survey. Diabetes Care 29(12):2701–2707CrossRefPubMed

30.

Lin SX, Pi-Sunyer EX (2007) Prevalence of the metabolic syndrome among US middle-aged and older adults with and without diabetes: a preliminary analysis of the NHANES 1999–2002 data. Ethn Dis 17(1):35–39PubMed

31.

Yadav D et al (2013) Prevalence of metabolic syndrome in type 2 diabetes mellitus using NCEP-ATPIII, IDF and WHO definition and its agreement in gwalior chambal region of central India. Glob J Health Sci 5(6):142–155CrossRefPubMedPubMedCentral

32.

Song SH, Hardisty CA (2008) Diagnosing metabolic syndrome in type 2 diabetes: does it matter? QJM 101(6):487–491CrossRefPubMed

33.

Pocock SJ (1983) Clinical trials: a practical approach. Wiley, Chichester, New York, Brisbane, Toronto, Singapore

34.

Polosa R, Morjaria JB, Caponnetto P et al (2016) Blood pressure control in smokers with arterial hypertension who switched to electronic cigarettes. Int J Environ Res Public Health 13(11):1123CrossRefPubMedPubMedCentral

35.

Polosa R, Morjaria JB, Caponnetto P et al (2016) Persisting long term benefits of smoking abstinence and reduction in asthmatic smokers who have switched to electronic cigarettes. Discov Med 21(114):99–108PubMed

36.

Polosa R, Morjaria JB, Prosperini U et al (2018) Health effects in COPD smokers who switch to electronic cigarettes: a retrospective-prospective 3-year follow-up. Int J Chron Obstruct Pulmon Dis 13:2533–2542CrossRefPubMedPubMedCentral

37.

Adriaens K, Van Gucht D, Declerck P et al (2014) Effectiveness of the electronic cigarette: an eight-week flemish study with six-month follow-up on smoking reduction, craving and experienced benefits and complaints. Int J Environ Res Public Health 11(11):11220–11248CrossRefPubMedPubMedCentral

38.

Polosa R, Caponnetto P, Maglia M et al (2014) Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit. BMC Public Health 14:1159CrossRefPubMedPubMedCentral

39.

European Commission 2021 Special Eurobarometer 506: attitudes of Europeans towards tobacco and electronic cigarettes. European Commission. https://data.europa.eu/data/datasets/s2240_506_eng?locale=en. Accessed 16 May 2023

40.

McNeill A, Brose L, Calder R, Simonavicius E, Robson D 2021 Vaping in England: evidence update February 2021: a report commissioned by Public Health England. London: public health England. https://www.gov.uk/government/publications/vaping-in-england-evidence-update-february-2021. Accessed 29 Apr 2023

41.

Jerzyński T, Stimson GV, Shapiro H, Król G (2021) Estimation of the global number of e-cigarette users in 2020. Harm Reduct J 18(1):109. https://doi.org/10.1186/s12954-021-00556-7.PMID:34688284;PMCID:PMC8541798CrossRefPubMedPubMedCentral

42.

Hori A, Tabuchi T, Kunugita N (2020) Rapid increase in heated tobacco product (HTP) use from 2015 to 2019: from the Japan ‘society and new tobacco’ internet survey (JASTIS). Tob Control 30(4):474–475. https://doi.org/10.1136/tobaccocontrol-2020-055652CrossRefPubMed

43.

Ratajczak A, Jankowski P, Strus P, Feleszko W (2020) Heat not burn tobacco product-a new global trend: impact of heat-not-burn tobacco products on public health, a systematic review. Int J Environ Res Public Health 17(2):409. https://doi.org/10.3390/ijerph17020409CrossRefPubMedPubMedCentral

44.

Miller CR, Sutanto E, Smith DM, Hitchman SC, Gravely S, Yong HH, Borland R, O’Connor RJ, Cummings KM, Fong GT, Hyland A, Quah ACK, Goniewicz ML (2022) Characterizing heated tobacco product use among adult cigarette smokers and nicotine vaping product users in the 2018 ITC four country smoking and vaping survey. Nicotine Tob Res 24(4):493–502. https://doi.org/10.1093/ntr/ntab217CrossRefPubMed

45.

Haziza C, de La Bourdonnaye G, Merlet S, Benzimra M, Ancerewicz J, Donelli A, Baker G, Picavet P, Lüdicke F (2016) Assessment of the reduction in levels of exposure to harmful and potentially harmful constituents in Japanese subjects using a novel tobacco heating system compared with conventional cigarettes and smoking abstinence: a randomized controlled study in confinement. Regul Toxicol Pharmacol 81:489–499. https://doi.org/10.1016/j.yrtph.2016.09.014CrossRefPubMed

46.

Gale N, McEwan M, Camacho OM, Hardie G, Murphy J, Proctor CJ (2021) Changes in biomarkers of exposure on switching from a conventional cigarette to the glo tobacco heating product: a randomized. Controll Ambul Study Nicotine Tob Res 23(3):584–591. https://doi.org/10.1093/ntr/ntaa135CrossRef

47.

Farsalinos KE, Polosa R (2014) Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf 5:67–86CrossRefPubMedPubMedCentral

48.

Daynard R (2018) Public health consequences of e-cigarettes: a consensus study report of the national academies of sciences, engineering, and medicine. J Public Health Pol 39:379–381CrossRef

49.

Polosa R, O’Leary R, Tashkin D, Emma R, Caruso M (2019) The effect of e-cigarette aerosol emissions on respiratory health: a narrative review. Expert Rev Respir Med 13(9):899–915CrossRefPubMed

50.

Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C (2013) A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J 4(10):19. https://doi.org/10.1186/1477-7517-10-19CrossRef

51.

Caruso M, Emma R, Distefano A, Rust S, Poulas K, Zadjali F, Giordano A, Volarevic V, Mesiakaris K, Al Tobi M, Boffo S, Arsenijevic A, Zuccarello P, Giallongo C, Ferrante M, Polosa R, Li Volti G, Replica Project Group (2021) Electronic nicotine delivery systems exhibit reduced bronchial epithelial cells toxicity compared to cigarette: the Replica Project. Sci Rep 11(1):24182. https://doi.org/10.1038/s41598-021-03310-yADSCrossRefPubMedPubMedCentral

Title: 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
Authors: Arkadiusz Krysiński
Cristina Russo
Davide Campagna
Antonino Di Pino
Sarah John
Jonathan Belsey
Pasquale Caponnetto
Lorina Vudu
Chong Wei Lim
Agostino Di Ciaula
Nicola Veronese
Mario Barbagallo
Farrukh Iqbal
David Fluck
Edward Franek
Riccardo Polosa
Pankaj Sharma
the DiaSmokeFree investigators
Publication date: 24-11-2023
Publisher: Springer International Publishing
Keywords: Combustion
Combustion
Smoking and Nicotine Detoxification
Type 2 Diabetes
Published in: Internal and Emergency Medicine / Issue 2/2024
Print ISSN: 1828-0447
Electronic ISSN: 1970-9366
DOI: https://doi.org/10.1007/s11739-023-03467-6

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