- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00037258
Dyslipidemia and Risk of Cardiovascular Disease in Diabetic Men and Women
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Piano di studio
Come è strutturato lo studio?
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Frank Hu, Harvard University School of Public Health
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Altri numeri di identificazione dello studio
- 1156
- R01HL065582 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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