Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00037258
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
69.9

Study Details

Study Description

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 Design

Study Type:
Observational
Study Start Date :
Sep 1, 2001
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    No eligibility criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • : Frank Hu, Harvard University School of Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Frank Hu, Professor of Nutrition and Epidemiology, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT00037258
    Other Study ID Numbers:
    • 1156
    • R01HL065582
    First Posted:
    May 17, 2002
    Last Update Posted:
    Apr 1, 2014
    Last Verified:
    Mar 1, 2014

    Study Results

    No Results Posted as of Apr 1, 2014