Cardiovascular Diseases Clinical Trial
To determine the role of dyslipidemia, markers of endothelial dysfunction genetic susceptibility, and dietary fat intake on the development of cardiovascular disease (CVD) complications in Type II diabetes mellitus.
BACKGROUND:
The cardiovascular disease complications of Type II diabetes mellitus are a major public
health problem. The research is designed to provide new information about the relation of
specific biomarkers, genes, and diet on risk of CVD complications in the high-risk Type II
diabetes mellitus population.
DESIGN NARRATIVE:
The study assesses biochemical markers of dyslipidemia and endothelial dysfunction, and
omega-3 fatty acids in relation to risk of CVD among men and women diagnosed with type 2
diabetes in two large ongoing cohort studies, the Nurses Health Study (NHS) and Health
Professionals Follow-up Study (HPFS). By 1998, 12,600 confirmed type 2 diabetic cases had
already accumulated in the two cohorts. By the year 2002, 5,507 blood samples prospectively
collected from persons with previously or newly diagnosed type 2 diabetes will be available
for analyses. Using this unparalleled resource, the investigators will evaluate (1) The
relationship between plasma levels of cell adhesion molecules (i.e. sICAM-1, sVCAM-1,
E-selectin), diabetic dyslipidemia, and risk of CVD among diabetics; (2) the association
between Lp(a) concentrations and risk of CVD among diabetics, independent of high
triglycerides and low HDL; (3) the association between long-term intakes of omega-3 fatty
acids and CVD risk in diabetes. The main NHS and HPFS grants will provide follow-up and
documentation of CVD in addition to covariate information. Overall, the large size of these
cohorts, the prospective design, the high follow-up rates, and the availability of archived
blood specimens provide a unique opportunity to study the relationship between diabetic
dyslipidemia and risk of CVD in an extremely cost-efficient and timely manner. In addition,
these two cohorts provide an unusual opportunity to compare lipid profiles and endothelial
markers of CVD between diabetic men and women.
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