Oivauni Sleep Clinic (EU-validated non-profit research entity, PIC 961156414) from Finland will be responsible for providing sleep part of the upcoming “Sleep disorders and diabetes in Europe-the effect of lifestyle intervention with weight reduction”-project. The study is a multi-centre trial (22 centres in 17 European countries) based on EU-funded Early Prevention of Diabetes Complications in Europe (ePREDICE)-study and will commence in the summer 2012.
Oivauni Sleep Clinic (EU-validated non-profit research entity, PIC 961156414) from Finland, will be responsible for providing sleep recording devices, training for all the clinical study centers and perform all the analyses of the sleep recordings regarding the upcoming “Sleep disorders and diabetes in Europe-the effect of lifestyle intervention with weight reduction”-project. Associate professor Henri Tuomilehto is a specialist of sleep medicine and the medical director of Sleep Clinic Oivauni and also principal investigator for the sleep part of the study. The study is a multi-centre trial (22 centres in 17 European countries) based on EU-funded Early Prevention of Diabetes Complications in Europe (ePREDICE)-study and will commence in the summer 2012. This is an innovative investigator initiated, non-commercial, clinical trial. The study is an interventional, long-term (5-year), randomised, open-label, lifestyle-controlled, four parallel groups trial with a total sample size of 3.000 individuals. Complete assessments (as at baseline) will be repeated at months 36th and 60th, including assessments of sleep (including nocturnal cardio-respiratory recordings). The primary aim of the proposal is to assess the effect of 3-year treatment with liraglutide, sitagliptine or metformin plus lifestyle intervention (diet and exercise), compared to lifestyle intervention alone, with a follow-up up to 5 years as a treatment of OSA and RLS in people with different degrees of hyperglycaemia. The proposal also aims to determine the impact of co-existing OSA and RLS in the likelihood of developing both micro- (biomarkers, endothelial function, intima-media thickness) and macrovascular (cardiovascular diseases, retinopathy) complications among people with hyperglycaemia, and further to identify the possible underlying mechanisms causing the association between OSA, RLS and hyperglycaemia.
Sleep disordered breathing, restless legs syndrome, sleep duration, type 2 diabetes, cardiovascular diseases, metabolism, lifestyle intervention
1. Tuomilehto H, Peltonen M, Partinen M, Seppä J, Timo Saaristo, Eeva Korpi-Hyövälti, Heikki Oksa, Juha Saltevo, Hannu Puolijoki, Mauno Vanhala, Jaakko Tuomilehto. Sleep duration is associated with an increased risk for the prevalence of type 2 diabetes in middle-aged women – the FIN-D2D survey. Sleep Medicine 2008;9(3):221-227.
2. Tuomilehto H, Peltonen M, Partinen M, Seppä J, Timo Saaristo, Eeva Korpi-Hyövälti, Heikki Oksa, Juha Saltevo, Hannu Puolijoki, Mauno Vanhala, Jaakko Tuomilehto. Sleep-disordered breathing is related to an increased risk for type 2 diabetes in middle-aged men, but not in women – the FIN D2D-survey. Diabetes Obes Metab. 2008;10(6):468-475.
3. Tuomilehto H, Peltonen M, Partinen M, Lavigne G, Eriksson JG, Aunola S, Keinänen-Kiukaanniemi S, Ilanne-Parikka P, Uusitupa M, Tuomilehto J, Lindström J. On the behalf of the Finnish Diabetes Prevention Study Group. Sleep duration, lifestyle intervention and incidence of type 2 diabetes in impaired glucose tolerance. The Finnish Diabetes Prevention Study. Diabetes Care. 2009 Nov;32(11):1965-71.
4. Tuomilehto H, Seppä J, Partinen M, Peltonen M, Gylling H, Tuomilehto J, Vanninen E, Kokkarinen J, Sahlman J, Martikainen T, Randell J, Tukiainen H, Uusitupa M. Lifestyle Intervention with Weight Reduction-First Line Treatment in Mild Obstructive Sleep Apnea. Am J Respir Crit Care Med 2009 Feb 15;179(4):320-7.
5. Tuomilehto H, Gylling H, Peltonen M, Martikainen T, Sahlman J, Kokkarinen J, Randell J, Tukiainen H, Vanninen E, Partinen M, Tuomilehto J, Uusitupa M, Seppä J. Sustained improvement in mild obstructive sleep apnea by diet and physical activity based lifestyle intervention- post-interventional follow-up. Am J Clin Nutr 2010;92:688-692.
6. Sahlman J, Herder C Seppä J, Peltonen M, Peuhkurinen K, Gylling H, Vanninen E, Tukiainen H, Partinen M, Uusitupa M, Tuomilehto H. Effect of lifestyle intervention on inflammation in patients with mild obstructive sleep apnoea. Nutr Metab Cardiovasc Dis. 2010 Dec 28. [Epub ahead of print]
8. Sahlman J, Peltonen M, Miettinen K, Punnonen K, Peuhkurinen K, Vanninen E, Tuomilehto H. Activation of inflammatory cytokine system in mild obstructive sleep apnea. J Sleep Res. 2010 Jun 1;19(2):341-348.