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.
RCT Entities:
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.
Authors: M I Harris; K M Flegal; C C Cowie; M S Eberhardt; D E Goldstein; R R Little; H M Wiedmeyer; D D Byrd-Holt Journal: Diabetes Care Date: 1998-04 Impact factor: 19.112
Authors: A D Morris; D I Boyle; A D McMahon; H Pearce; J M Evans; R W Newton; R T Jung; T M MacDonald Journal: Diabetes Care Date: 1997-09 Impact factor: 19.112
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Authors: Thomas A Buchanan; Anny H Xiang; Ruth K Peters; Siri L Kjos; Aura Marroquin; Jose Goico; Cesar Ochoa; Sylvia Tan; Kathleen Berkowitz; Howard N Hodis; Stanley P Azen Journal: Diabetes Date: 2002-09 Impact factor: 9.461
Authors: Marij Gielen; Geja J Hageman; Evangelia E Antoniou; Katarina Nordfjall; Massimo Mangino; Muthuswamy Balasubramanyam; Tim de Meyer; Audrey E Hendricks; Erik J Giltay; Steven C Hunt; Jennifer A Nettleton; Klelia D Salpea; Vanessa A Diaz; Ramin Farzaneh-Far; Gil Atzmon; Sarah E Harris; Lifang Hou; David Gilley; Iiris Hovatta; Jeremy D Kark; Hisham Nassar; David J Kurz; Karen A Mather; Peter Willeit; Yun-Ling Zheng; Sofia Pavanello; Ellen W Demerath; Line Rode; Daniel Bunout; Andrew Steptoe; Lisa Boardman; Amelia Marti; Belinda Needham; Wei Zheng; Rosalind Ramsey-Goldman; Andrew J Pellatt; Jaakko Kaprio; Jonathan N Hofmann; Christian Gieger; Giuseppe Paolisso; Jacob B H Hjelmborg; Lisa Mirabello; Teresa Seeman; Jason Wong; Pim van der Harst; Linda Broer; Florian Kronenberg; Barbara Kollerits; Timo Strandberg; Dan T A Eisenberg; Catherine Duggan; Josine E Verhoeven; Roxanne Schaakxs; Raffaela Zannolli; Rosana M R Dos Reis; Fadi J Charchar; Maciej Tomaszewski; Ute Mons; Ilja Demuth; Andrea Elena Iglesias Molli; Guo Cheng; Dmytro Krasnienkov; Bianca D'Antono; Marek Kasielski; Barry J McDonnell; Richard Paul Ebstein; Kristina Sundquist; Guillaume Pare; Michael Chong; Maurice P Zeegers Journal: Am J Clin Nutr Date: 2018-09-01 Impact factor: 7.045