Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank Hu, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00037258
First received: May 16, 2002
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition
Cardiovascular Diseases
Diabetes Mellitus, Non-insulin Dependent
Heart Diseases
Atherosclerosis
Diabetes Mellitus

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Study Start Date: September 2001
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037258

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Investigator: Frank Hu Harvard University School of Public Health
  More Information

Publications:

Responsible Party: Frank Hu, Professor of Nutrition and Epidemiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00037258     History of Changes
Other Study ID Numbers: 1156, R01HL065582
Study First Received: May 16, 2002
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014