@article{e2a1e9ded2f64800ae791a2c93882776,
title = "Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: The DREAM trial",
abstract = "Aims/hypothesis. Diabetes is a rapidly rising independent risk factor for atherosclerosis and serious illness. This risk can be reduced by lifestyle changes and/or various drugs. Novel therapies to prevent diabetes, as well as new risk factors for diabetes, atherosclerosis and obesity require testing and identification. Methods. People with impaired fasting glucose or impaired glucose tolerance were randomised to ramipril (15 mg/day) or placebo and rosiglitazone (8 mg/day) or placebo with a 2x2 factorial design. They are assessed semi-annually for the primary outcome (diabetes or death). Diabetes is diagnosed if two consecutive plasma glucose levels exceed diagnostic thresholds (i.e. fasting ≥7.0 mmol/l or 2-h >11.1 mmol/l) within a 3-month period. Assuming an annual primary outcome incidence of 5%, there is more than 90% power to detect a 22% reduction. Approximately 20% of participants are having annual carotid ultrasounds to assess the effects on atherosclerosis. Patients screened but not randomised are being followed prospectively to identify determinants of obesity, diabetes and related disorders. Results. A total of 24,872 individuals in 21 countries were screened over 2 years and are eligible for follow-up. Of these, 5269 were randomised: 1835 (35%) had isolated impaired glucose tolerance, 739 (14%) had isolated impaired fasting glucose, and 2692 (51%) had both disorders. Annual carotid ultrasounds are currently being performed in 1406 randomised individuals. Conclusions/interpretation. The DREAM trial and related studies will determine if ramipril or rosiglitazone reduces the number of cases of diabetes and atherosclerosis, and will identify novel risk factors for diabetes.",
keywords = "Design, Diabetes prevention, Ramipril, Rosiglitazone, Trial",
author = "{The Dream Trial Investigators} and Gerstein, {H. C.} and S. Yusuf and R. Holman and J. Bosch and J. Pogue and H. Gerstein and G. Dagenais and J. Probstfield and S. Anand and A. Avezum and A. Budaj and S. Capes and Chiasson, {J. L.} and V. Christian and I. Conget and M. Davies and R. Diaz and N. Dinccag and A. Escalante and G. Fodor and M. Freed and M. Hanefeld and A. Hartung and A. Himmelmann and M. Keltai and M. Laakso and F. Lanas and E. Lonn and M. McQueen and V. Mohan and W. Schulz and I. Schmid and J. Shaw and K. Teo and P. Zimmet and B. Zinman and {Ahuad Guerrero}, {R. A.} and Albisu, {J. P.} and {Amado Eleas}, {M. A.} and V. Arregui and Avaca, {H. A.} and Baglivo, {H. P.} and Bello, {F. H.} and J. Bono and A. Caccavo and Caime, {G. D.} and Cartasegna, {L. R.} and Casabe, {J. H.} and R. Castellanos and Castro, {L. A.} and M. Centeno and Citta, {L. N.} and N. Citta and Cuneo, {C. A.} and {de Loredo}, L. and Denaro, {R. H.} and {de Rosa}, {J. F.} and Esperatti, {E. M.} and H. Farras and A. Fernandez and Ferrari, {G. M.} and Gambarte, {A. J.} and M. Garrido and A. Hershon and Klyver, {M. I.} and Laugle, {C. T.} and Liberman, {A. G.} and {Lobo Marquez}, {L. L.} and Lopez, {R. R.} and Lowenstein, {J. A.} and C. Luquez and I. Mackinnon and Maffia, {M. C.} and Majul, {C. R.} and Marzetti, {E. M.} and O. Manuale and G. Marcucci and Martos, {M. S.} and R. Memoli and O. Montana and A. Orlandini and Piasentin, {J. A.} and Pignolo, {G. A.} and D. Piskorz and Plastino, {M. L.} and Pomposiello, {J. C.} and C. Ramos and Ramos, {F. H.} and H. Ramos and A. Risolo and Saavedra, {S. S.} and L. Sago and R. Sanchez and Schygeil, {P. O.} and O. Sotomayor and M. Vico and Vico, {M. L.} and {Vizcaya Castro}, {A. J.D.} and Zaidman, {C. J.} and C. Allen and P. Buchanan and D. Calvert and M. Cochran and S. Colagiuri and P. Colman and M. Correcha and M. D{\textquoteright}emden and J. Freeborn and H. Friebel and G. Fulcher and C. Glatthaar and J. Graham and P. Hackney and V. Heazlewood and B. Higgins and J. Karrasch and A. Marangou and A. Matthiesson and K. Michaelis and R. Moses and V. Naidu and A. Nankervis and R. O{\textquoteright}brien and H. Parry and P. Patrikios and N. Petrovsky and J. Proietto and A. Roberts and C. Rodgers and G. Ross and R. Simpson and R. Slobodniuk and B. Stuckey and D. Topliss and J. Twomey and J. Walsh and J. Warner and S. Wigg and S. Wu and D. Yue and R. Yuen and S. Marshall and Bertolami, {M. C.} and J. Borges and {Branco de Araujo}, D. and {Da Silva}, {A. F.} and {Do Socorro}, M. and Faludi, {A. A.} and S. Grespan and Gross, {J. L.} and A. Halpern and Hirota, {A. H.} and C. Leiteo and O. Monte and {Nunes Salles}, {J. E.} and O. Oliveira and A. Rabelo and Rabelo, {L. M.} and Turatti, {L. A.} and H. Zatz and C. Abbot and Bakare, {A. Abu} and M. Ali and Allison, {R. C.} and Beauchef, {J. P.} and A. Belanger and B. Bell and G. Bondy and P. Bonin and R. Bouchard and P. Bragaglia and S. Brault and R. Brossoit and B. Caloyannis and J. Cha and L. Chalklin and P. Champion and S. Chan and Y. Chan and R. Cheung and M. Chilvers and Conway, {J. R.} and Czolpinski, {T. R.} and R. Denton and D. Donat and M. Drapeau and R. Dumas and S. Duncan and H. Duong and D. Eddy and D. Fay and D. Feig and L. Fischer and F. Fraser and L. Frenette and J. Frohlich and Fyfe, {M. L.} and Gagnon, {J. A.} and G. Girard and J. McGill",
note = "Funding Information: Acknowledgements. The DREAM trial is funded by the Canadian Institutes of Health Research (MCT41548) as well as by Aventis Pharma, GlaxoSmithKline, King Pharmaceuticals and Wyeth Ayerst.",
year = "2004",
month = sep,
day = "1",
doi = "10.1007/s00125-004-1485-5",
language = "English",
volume = "47",
pages = "1519--1527",
journal = "Diabetologia",
issn = "0012-186X",
number = "9",
}