Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women

Completed

• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Non-insulin Dependent; Heart Diseases; Atherosclerosis; Diabetes Mellitus

• Registration Number: NCT00037258
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-05-16
• Study First Submitted QC: 2002-05-16
• Study First Posted: 2002-05-17
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified