“DREAM,” Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication–A Randomized, Placebo-Controlled Trial   Sponsor     Aventis   Principal Investigators     McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada Hertzel Gerstein, MD, Professor of Medicine and Chief of Division of Endocrinology Salim Yusuf, MD, Professor of Medicine and Chief of Division of Cardiology   Principal Investigator for U.S. Regional Coordinating Center     Jeffery Probstfield, MD, University of Washington School of Medicine   Berman Center Site Investigator     Sarah Kempainen, MD   Berman Center Site Coordinator     Sandra Graham, RN 612-341-7923   Description     DREAM is an international, multi-center, randomized, double-blinded, placebo-controlled trial involving 4,000 participants at high risk for developing type II diabetes mellitus. The study is a 2x2 factorial involving ramipril (ACE-I) (active vs. placebo) and rosiglitazone (TZD) (active vs. placebo). The goal is to determine which combination of therapies leads to a lower prospective incidence of DM. The study also collects observational data useful for establishing epidemiological associations between cardiovascular disease and type II diabetes mellitus.   Role of the Berman Center     Between July 2002 and July 2003, the Berman Center recruited and screened 162 prospective participants. Of these, the Berman Center enrolled and randomized 30 individuals into DREAM and obtained consent from 132 individuals to be enrolled in EpiDREAM, an observational sub-study of DREAM. The Berman Center referred all EpiDREAM participants to the University of Washington School of Medicine, which is the US Regional Coordinating Center for both studies. DREAM participants will be followed for 3 years, through 2006. During the 3-year follow-up, DREAM participants visit the Berman Center 10 times (every 2-6 months), where study physicians and research nurses take laboratory and physical measurements.   Abstract     DREAM is a randomized, double-blinded, placebo-controlled trial involving 4,000 participants at high risk for developing type II diabetes mellitus. Coordinated by the Population Health Research Institute in Hamilton, Ontario Canada, participants are recruited by 138 clinical sites, 22 of which are in the U.S. Participants who have either impaired glucose tolerance or fasting glucose levels >110mg/dL and <126mg/dL, are randomized to receive either ramipril (ACE-I) or rosiglitazone (TZD). The primary endpoint is development of type II diabetes mellitus during the next three years. EpiDREAM, a sub-study of DREAM, is expected to enroll approximately 15,000 high-risk individuals who are ineligible for DREAM. For the duration of DREAM, EpiDREAM participants will provide yearly updates on health status by telephone interview.