, Volume 47, Issue 9, pp 1519-1527
Date: 21 Aug 2004

Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM trial

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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 2×2 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.

Corresponding author of the DREAM trial: H.C. Gerstein, c/o DREAM Project Office
Please address reprint requests to: DREAM Project Office, Population Health Research Institute, 237 Barton Street East, 2nd Floor, Hamilton, Ontario L8L 2X2, Canada, E-mail: dream@ccc.mcmaster.ca
The DREAM Trial Investigators as of December 2003 are listed at the end of the paper