Project: Research project

Project Details


DESCRIPTION (provided by applicant):
The Diabetes Prevention Program is a multicenter controlled clinical trial
examining the efficacy of an intensive life-style intervention or metformin to
prevent or delay the development of diabetes in a population selected to be at
high risk due to the presence of impaired glucose tolerance (IGT). Development
of diabetes, defined by 1997 ADA criteria, is the primary outcome while
cardiovascular disease and its risk factors are important secondary outcomes.
The DPP began recruitment in mid-1996. At the time of this application, total
study exposure is a mean of approximately 3 years (range 2 to 5) with a total
of approximately 10,000 patient years in the 3,234 volunteers in the 3-arm
study. On the basis of a statistically significant and clinically compelling
decrease in the development of diabetes in the life-style intervention and
metformin-treated groups (58% and 31% reductions, respectively) compared with
the placebo treated group, the DPP Data Monitoring Board and NIDDK ended the
masked treatment phase of the study in May, 2001, one year earlier than
originally planned.
This application is designed to take further advantage of the scientifically
and clinically valuable cohort of DPP volunteers and the large volume of data
collected during the study. The highly compliant DPP cohort, including 45%
minorities, is the largest IGT population ever studied. Moreover, the subcohort
that has developed diabetes (n approximately 700) has been followed from near
the exact time of diabetes onset. Clinically important research questions
remain in the wake of the DPP. The carefully collected, centrally measured and
graded data in this cohort should help to answer, definitively, a number ofvolunteers with impaired glucose tolerance and volunteers whose diabetes
developed during the DPP to determine the natural history of diabetic
complications. This analysis will be epidemiologic in nature with all groups
being pooled with prior treatment being used as a co-variate. Finally, the same
data will be used to examine the effects of gender, age, and race/ethnicity on
diabetes and its vascular complication.
Effective start/end date8/15/941/31/22


  • Endocrinology, Diabetes and Metabolism
  • Medicine(all)


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