Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
Primary Purpose
Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037258
First Posted
May 16, 2002
Last Updated
March 28, 2014
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00037258
Brief Title
Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
Study Type
Observational
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases, Atherosclerosis, Diabetes Mellitus
7. Study Design
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hu
Organizational Affiliation
Harvard University School of Public Health
12. IPD Sharing Statement
Citations:
PubMed Identifier
12668520
Citation
Hu FB, Cho E, Rexrode KM, Albert CM, Manson JE. Fish and long-chain omega-3 fatty acid intake and risk of coronary heart disease and total mortality in diabetic women. Circulation. 2003 Apr 15;107(14):1852-7. doi: 10.1161/01.CIR.0000062644.42133.5F. Epub 2003 Mar 31.
Results Reference
background
PubMed Identifier
11755014
Citation
Goldberger AL, Peng CK, Lipsitz LA. What is physiologic complexity and how does it change with aging and disease? Neurobiol Aging. 2002 Jan-Feb;23(1):23-6. doi: 10.1016/s0197-4580(01)00266-4. No abstract available.
Results Reference
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PubMed Identifier
15159229
Citation
Tanasescu M, Cho E, Manson JE, Hu FB. Dietary fat and cholesterol and the risk of cardiovascular disease among women with type 2 diabetes. Am J Clin Nutr. 2004 Jun;79(6):999-1005. doi: 10.1093/ajcn/79.6.999.
Results Reference
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PubMed Identifier
15502925
Citation
Shai I, Rimm EB, Schulze MB, Rifai N, Stampfer MJ, Hu FB. Moderate alcohol intake and markers of inflammation and endothelial dysfunction among diabetic men. Diabetologia. 2004 Oct;47(10):1760-7. doi: 10.1007/s00125-004-1526-0. Epub 2004 Oct 22.
Results Reference
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PubMed Identifier
15277429
Citation
Jiang R, Schulze MB, Li T, Rifai N, Stampfer MJ, Rimm EB, Hu FB. Non-HDL cholesterol and apolipoprotein B predict cardiovascular disease events among men with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1991-7. doi: 10.2337/diacare.27.8.1991.
Results Reference
background
PubMed Identifier
15257998
Citation
Skinner HG, Michaud DS, Giovannucci EL, Rimm EB, Stampfer MJ, Willett WC, Colditz GA, Fuchs CS. A prospective study of folate intake and the risk of pancreatic cancer in men and women. Am J Epidemiol. 2004 Aug 1;160(3):248-58. doi: 10.1093/aje/kwh214.
Results Reference
background
PubMed Identifier
15220246
Citation
Schulze MB, Rimm EB, Shai I, Rifai N, Hu FB. Relationship between adiponectin and glycemic control, blood lipids, and inflammatory markers in men with type 2 diabetes. Diabetes Care. 2004 Jul;27(7):1680-7. doi: 10.2337/diacare.27.7.1680.
Results Reference
background
PubMed Identifier
15047644
Citation
Schulze MB, Rimm EB, Li T, Rifai N, Stampfer MJ, Hu FB. C-reactive protein and incident cardiovascular events among men with diabetes. Diabetes Care. 2004 Apr;27(4):889-94. doi: 10.2337/diacare.27.4.889.
Results Reference
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PubMed Identifier
15883237
Citation
Choi HK, Willett WC, Stampfer MJ, Rimm E, Hu FB. Dairy consumption and risk of type 2 diabetes mellitus in men: a prospective study. Arch Intern Med. 2005 May 9;165(9):997-1003. doi: 10.1001/archinte.165.9.997.
Results Reference
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PubMed Identifier
15855561
Citation
Qi L, Rimm E, Liu S, Rifai N, Hu FB. Dietary glycemic index, glycemic load, cereal fiber, and plasma adiponectin concentration in diabetic men. Diabetes Care. 2005 May;28(5):1022-8. doi: 10.2337/diacare.28.5.1022.
Results Reference
background
PubMed Identifier
15755822
Citation
Wang Y, Rimm EB, Stampfer MJ, Willett WC, Hu FB. Comparison of abdominal adiposity and overall obesity in predicting risk of type 2 diabetes among men. Am J Clin Nutr. 2005 Mar;81(3):555-63. doi: 10.1093/ajcn/81.3.555.
Results Reference
background
PubMed Identifier
15677512
Citation
Schulze MB, Shai I, Rimm EB, Li T, Rifai N, Hu FB. Adiponectin and future coronary heart disease events among men with type 2 diabetes. Diabetes. 2005 Feb;54(2):534-9. doi: 10.2337/diabetes.54.2.534.
Results Reference
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Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
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