Interventional - Drug
The objective of the DREAM ON study was to show that rosiglitazone substantially reduced the risk of diabetes and increased regression to normoglycemia in people with either impaired fasting glucose and/or impaired glucose tolerance. The two-month washout suggested that there was durability of this effect after stopping rosiglitazone. However, this may have been influenced by the long half-life of rosiglitazone.
Clear evidence within the DREAM trial that rosiglitazone increased hip circumference and reduced the waist/hip ratio and ALT levels, and animal data suggesting that rosiglitazone may preserve beta cell mass and function, suggests that the median three years of exposure to rosiglitazone in DREAM may have an even longer-term effect on the prevention of diabetes and its consequences. Such an effect would be detectable by further open follow-up of the DREAM cohort, and will be assessed in the passive DREAM ON follow-up study.
The DREAM trial also showed that ramipril clearly increased regression to normoglycemia by 17%, and reported a nonsignificant 9% reduction in diabetes incidence. Whether or not the effect on regression means that longer treatment and follow-up would detect an effect on diabetes prevention remains unknown. This possibility was assessed in the DREAM ON study.
A) Do DREAM trial participants without diabetes, who were allocated to rosiglitazone for a median of three years during the active treatment phase, have a significantly lower incidence of the primary outcome of diabetes or death compared to the group allocated to placebo (regardless of subsequent therapy) during the full follow-up period (i.e. the active treatment phase plus the passive observation phase)?
B) Do DREAM trial participants without diabetes, who were allocated to ramipril for a median of three years during the active treatment phase, have a significantly lower incidence of the primary outcome of diabetes or death compared to the group allocated to placebo (regardless of subsequent therapy) during the full follow-up period (i.e. the active treatment phase plus the passive observation phase)?
Interventional - Drug
Deputy Director; Senior Scientist
Hertzel Gerstein is Deputy Director, PHRI, and our Senior Scientific Program Lead, Diabetes, as well as a Professor, Medicine, McMaster University. He is also Director of the Division of Endocrinology & Metabolism and Director of the Diabetes Care and Research Program. He has pioneered the application of large simple outcome trials to people with diabetes globally, and developed the concept of dysglycemia as an important risk factor for many of the serious health outcomes that afflict people with an elevated glucose level regardless of diabetes status. He currently leads clinical trials and epidemiological studies related to: a) the prevention and therapy of diabetes and its many consequences, and b) the role of dysglycemia and relative insulin insufficiency on the development of diabetes, cardiovascular disease, cognitive impairment and other chronic conditions. Key studies in which he has played or continues to play a major leadership role include HOPE, MICRO HOPE, ACCORD, DREAM, EpiDREAM, ORIGIN, TIDE, ACE, ELIXA and REWIND.
Hertzel Gerstein has published more than 300 papers, editorials and commentaries, mainly on diabetes-related issues and co-edited the textbook Evidence-Based Diabetes Care. He is an Associate Editor for ACP Journal Club, and is on the editorial board of the Journal of Diabetes and Lancet Diabetes and Endocrinology. He has received several honors including the Canadian Diabetes Association’s Young Scientist Award (1999), Frederick G. Banting award (1999), Charles H. Best award (2007) and Lifetime Achievement Award (2012).
Jackie Bosch started working with Salim Yusuf in 1993, before PHRI was formally created, as she was completing her Masters in Clinical Epidemiology, with the intent to learn how to do clinical trials so she could run trials in post-stroke rehabilitation. Most recently, she has been a co-investigator on large trials in primary and secondary prevention of cardiovascular disease and diabetes, as well as understanding the causes of functional decline as well as developing simple, internationally applicable interventions to improve post-stroke disability.
She is Assistant Dean of the Occupational Therapy program, School of Rehabilitation Sciences, McMaster University, and has received awards such as the (McMaster) President’s Award for Outstanding Service, and the PHRI Award for Outstanding Contributions to Global Collaborations. She has more than 65 peer-reviewed publications.
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