We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Daniela Saitta, PhD
00390954781124
daniela.saitta@eclatrbc.it
Riccardo Polosa, PhD
00390953781566
polosa@unict.it
Diabetes Mellitus Metabolic Syndrome Diabetes Mellitus, Type 2
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
The investigators 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Fowler MJ. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes. 2011;29:116-22."; null; "Pan A, Wang Y, Talaei M, Hu FB, Wu T. Relation of active, passive, and quitting smoking with incident type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Dec;3(12):958-67. doi: 10.1016/S2213-8587(15)00316-2. Epub 2015 Sep 18."; "26388413"; "Wei M, Gaskill SP, Haffner SM, Stern MP. Effects of diabetes and level of glycemia on all-cause and cardiovascular mortality. The San Antonio Heart Study. Diabetes Care. 1998 Jul;21(7):1167-72. doi: 10.2337/diacare.21.7.1167."; "9653614"; "Al-Delaimy WK, Manson JE, Solomon CG, Kawachi I, Stampfer MJ, Willett WC, Hu FB. Smoking and risk of coronary heart disease among women with type 2 diabetes mellitus. Arch Intern Med. 2002 Feb 11;162(3):273-9. doi: 10.1001/archinte.162.3.273."; "11822919"; "Chuahirun T, Simoni J, Hudson C, Seipel T, Khanna A, Harrist RB, Wesson DE. Cigarette smoking exacerbates and its cessation ameliorates renal injury in type 2 diabetes. Am J Med Sci. 2004 Feb;327(2):57-67. doi: 10.1097/00000441-200402000-00001."; "14770020"; "Qin R, Chen T, Lou Q, Yu D. Excess risk of mortality and cardiovascular events associated with smoking among patients with diabetes: meta-analysis of observational prospective studies. Int J Cardiol. 2013 Jul 31;167(2):342-50. doi: 10.1016/j.ijcard.2011.12.100. Epub 2012 Jan 16."; "22251416"; "Pan A, Wang Y, Talaei M, Hu FB. Relation of Smoking With Total Mortality and Cardiovascular Events Among Patients With Diabetes Mellitus: A Meta-Analysis and Systematic Review. Circulation. 2015 Nov 10;132(19):1795-804. doi: 10.1161/CIRCULATIONAHA.115.017926. Epub 2015 Aug 26."; "26311724"; "Cacciola RR, Guarino F, Polosa R. Relevance of endothelial-haemostatic dysfunction in cigarette smoking. Curr Med Chem. 2007;14(17):1887-92. doi: 10.2174/092986707781058832."; "17627524"; "Stanton CA, Keith DR, Gaalema DE, Bunn JY, Doogan NJ, Redner R, Kurti AN, Roberts ME, Higgins ST. Trends in tobacco use among US adults with chronic health conditions: National Survey on Drug Use and Health 2005-2013. Prev Med. 2016 Nov;92:160-168. doi: 10.1016/j.ypmed.2016.04.008. Epub 2016 Apr 15."; "27090919"; "Ford ES, Mokdad AH, Gregg EW. Trends in cigarette smoking among US adults with diabetes: findings from the Behavioral Risk Factor Surveillance System. Prev Med. 2004 Dec;39(6):1238-42. doi: 10.1016/j.ypmed.2004.04.039."; "15539062"; "Caponnetto P, Russo C, Polosa R. Smoking cessation: present status and future perspectives. Curr Opin Pharmacol. 2012 Jun;12(3):229-37. doi: 10.1016/j.coph.2012.02.005. Epub 2012 Mar 5."; "22398322"; "Polosa R, Benowitz NL. Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci. 2011 May;32(5):281-9. doi: 10.1016/j.tips.2010.12.008. Epub 2011 Jan 20."; "21256603"; "Nagrebetsky A, Brettell R, Roberts N, Farmer A. Smoking cessation in adults with diabetes: a systematic review and meta-analysis of data from randomised controlled trials. BMJ Open. 2014 Mar 6;4(3):e004107. doi: 10.1136/bmjopen-2013-004107."; "24604481"; "Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10:19. doi: 10.1186/1477-7517-10-19."; "24090432"; "Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430."; "25083263"; "Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. 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. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available."; "11368702"; "Metascreen Writing Committee; Bonadonna R, Cucinotta D, Fedele D, Riccardi G, Tiengo A. 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. 2006 Dec;29(12):2701-7. doi: 10.2337/dc06-0942."; "17130208"; "Lin SX, Pi-Sunyer EX. 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. 2007 Winter;17(1):35-9."; "17274207"; "Yadav D, Mahajan S, Subramanian SK, Bisen PS, Chung CH, Prasad GB. 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. 2013 Sep 17;5(6):142-55. doi: 10.5539/gjhs.v5n6p142."; "24171882"; "Song SH, Hardisty CA. Diagnosing metabolic syndrome in type 2 diabetes: does it matter? QJM. 2008 Jun;101(6):487-91. doi: 10.1093/qjmed/hcn034. Epub 2008 Mar 19."; "18353792"; "Didangelos TP, Thanopoulou AK, Bousboulas SH, Sambanis CL, Athyros VG, Spanou EA, Dimitriou KC, Pappas SI, Karamanos BG, Karamitsos DT. The ORLIstat and CArdiovascular risk profile in patients with metabolic syndrome and type 2 DIAbetes (ORLICARDIA) Study. Curr Med Res Opin. 2004 Sep;20(9):1393-401. doi: 10.1185/030079904125004466."; "15383188"; "Bo S, Ciccone G, Baldi C, Benini L, Dusio F, Forastiere G, Lucia C, Nuti C, Durazzo M, Cassader M, Gentile L, Pagano G. Effectiveness of a lifestyle intervention on metabolic syndrome. A randomized controlled trial. J Gen Intern Med. 2007 Dec;22(12):1695-703. doi: 10.1007/s11606-007-0399-6. Epub 2007 Oct 6."; "17922167"; "Christensen P, Bliddal H, Riecke BF, Leeds AR, Astrup A, Christensen R. Comparison of a low-energy diet and a very low-energy diet in sedentary obese individuals: a pragmatic randomized controlled trial. Clin Obes. 2011 Feb;1(1):31-40. doi: 10.1111/j.1758-8111.2011.00006.x."; "25586973"; "Yoon NH, Yoo S, Kim H, Han Y. Routine Screening and Consultation Facilitate Improvement of Metabolic Syndrome. J Korean Med Sci. 2015 Aug;30(8):1092-100. doi: 10.3346/jkms.2015.30.8.1092. Epub 2015 Jul 15."; "26240487"; "Sharip, A., Firek, A., & Tonstad, S. The Effects of Smoking Cessation on the Risk Factors for the Metabolic Syndrome: A Follow-Up Study of Veterans. Journal of Smoking Cessation 2017, 12(3), 143-152. doi:10.1017/jsc.2016.10"; null; "Polosa R, Morjaria JB, Caponnetto P, Battaglia E, Russo C, Ciampi C, Adams G, Bruno CM. Blood Pressure Control in Smokers with Arterial Hypertension Who Switched to Electronic Cigarettes. Int J Environ Res Public Health. 2016 Nov 11;13(11):1123. doi: 10.3390/ijerph13111123."; "27845734"; "Polosa R, Morjaria JB, Caponnetto P, Caruso M, Campagna D, Amaradio MD, Ciampi G, Russo C, Fisichella A. Persisting long term benefits of smoking abstinence and reduction in asthmatic smokers who have switched to electronic cigarettes. Discov Med. 2016 Feb;21(114):99-108."; "27011045"; "Polosa R, Morjaria JB, Prosperini U, Russo C, Pennisi A, Puleo R, Caruso M, Caponnetto P. Health effects in COPD smokers who switch to electronic cigarettes: a retrospective-prospective 3-year follow-up. Int J Chron Obstruct Pulmon Dis. 2018 Aug 22;13:2533-2542. doi: 10.2147/COPD.S161138. eCollection 2018."; "30197510"; "Adriaens K, Van Gucht D, Declerck P, Baeyens F. 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. 2014 Oct 29;11(11):11220-48. doi: 10.3390/ijerph111111220."; "25358095"; "Polosa R, Caponnetto P, Maglia M, Morjaria JB, Russo C. Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit. BMC Public Health. 2014 Nov 8;14:1159. doi: 10.1186/1471-2458-14-1159."; "25380748"; "Pocock SJ. Clinical Trials: A practical approach. Wiley 1983"; null; "Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornoe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011."; "28854085"; "Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232-42. doi: 10.1056/NEJMoa1501352. Epub 2015 Jun 8. Erratum In: N Engl J Med. 2015 Aug 6;373(6):586. doi: 10.1056/NEJMx150029."; "26052984"; "Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15."; "27633186"; "Buckley JP, Sim J, Eston RG, Hession R, Fox R. Reliability and validity of measures taken during the Chester step test to predict aerobic power and to prescribe aerobic exercise. Br J Sports Med. 2004 Apr;38(2):197-205. doi: 10.1136/bjsm.2003.005389."; "15039259"; "Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91. doi: 10.1023/a:1026485130100."; "10457741"; "Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x."; "1932883"; "Florez H, Temprosa MG, Orchard TJ, Mather KJ, Marcovina SM, Barrett-Connor E, Horton E, Saudek C, Pi-Sunyer XF, Ratner RE, Goldberg RB; Diabetes Prevention Program Research Group. Metabolic syndrome components and their response to lifestyle and metformin interventions are associated with differences in diabetes risk in persons with impaired glucose tolerance. Diabetes Obes Metab. 2014 Apr;16(4):326-33. doi: 10.1111/dom.12220. Epub 2013 Oct 29."; "24118860"; "Krysinski A, Russo C, John S, Belsey JD, Campagna D, Caponnetto P, Vudu L, Lim CW, Purrello F, Di Mauro M, Iqbal F, Fluck D, Franek E, Polosa R, Sharma P; DIASMOKE collaborators. International randomised controlled trial evaluating metabolic syndrome in type 2 diabetic cigarette smokers following switching to combustion-free nicotine delivery systems: the DIASMOKE protocol. BMJ Open. 2021 Apr 27;11(4):e045396. doi: 10.1136/bmjopen-2020-045396."; "33906842"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Riccardo Polosa, PhD
00390953781566
polosa@unict.it
Daniela Saitta, PhD
00390954781124
daniela.saitta@eclatrbc.it
The study is sponsored by Eclat Srl. and is in collaboration with University of Catania.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
