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Epidemiology of Impaired Coagulant Balance in Diabetes

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005481
    Brief Title
    Epidemiology of Impaired Coagulant Balance in Diabetes
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the nature, extent and molecular mechanisms responsible for impaired fibrinolysis in White, Black, Hispanic and American Indian populations with respect to the presence or absence of diabetes. The overall objective is to determine whether impairments of fibrinolysis underlie subclinical and clinical vascular disease in diabetes in specific populations with and without accelerated microvascular disease.
    Detailed Description
    BACKGROUND: The results of this project should clarify the extent to which results obtained in experimental animals pertain directly to diabetes in human subjects. The study will also assist in the interpretation of results from clinical studies and from platelet activation experiments. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Blood Coagulation Disorders

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Russell Tracy
    Organizational Affiliation
    University of Vermont

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10554706
    Citation
    Tracy RP. Inflammation markers and coronary heart disease. Curr Opin Lipidol. 1999 Oct;10(5):435-41. doi: 10.1097/00041433-199910000-00008.
    Results Reference
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    PubMed Identifier
    9819003
    Citation
    Smiles AM, Macy EM, Sakkinen PA, Bovill EG, Mann KG, Tracy RP. Variability in plasma prothrombin concentration: implications for use in epidemiology. Blood Coagul Fibrinolysis. 1998 Sep;9(6):525-31. doi: 10.1097/00001721-199809000-00010.
    Results Reference
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    PubMed Identifier
    11916936
    Citation
    Festa A, D'Agostino R Jr, Tracy RP, Haffner SM; Insulin Resistance Atherosclerosis Study. Elevated levels of acute-phase proteins and plasminogen activator inhibitor-1 predict the development of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2002 Apr;51(4):1131-7. doi: 10.2337/diabetes.51.4.1131.
    Results Reference
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    PubMed Identifier
    11776319
    Citation
    Lewis MR, Callas PW, Jenny NS, Tracy RP. Longitudinal stability of coagulation, fibrinolysis, and inflammation factors in stored plasma samples. Thromb Haemost. 2001 Dec;86(6):1495-500.
    Results Reference
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    PubMed Identifier
    11673759
    Citation
    Festa A, D'Agostino R Jr, Williams K, Karter AJ, Mayer-Davis EJ, Tracy RP, Haffner SM. The relation of body fat mass and distribution to markers of chronic inflammation. Int J Obes Relat Metab Disord. 2001 Oct;25(10):1407-15. doi: 10.1038/sj.ijo.0801792.
    Results Reference
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    PubMed Identifier
    12145182
    Citation
    Hanley AJ, Karter AJ, Festa A, D'Agostino R Jr, Wagenknecht LE, Savage P, Tracy RP, Saad MF, Haffner S; Insulin Resistance Atherosclerosis Study. Factor analysis of metabolic syndrome using directly measured insulin sensitivity: The Insulin Resistance Atherosclerosis Study. Diabetes. 2002 Aug;51(8):2642-7. doi: 10.2337/diabetes.51.8.2642.
    Results Reference
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    PubMed Identifier
    12421431
    Citation
    Festa A, D'Agostino R Jr, Tracy RP, Haffner SM. C-reactive protein is more strongly related to post-glucose load glucose than to fasting glucose in non-diabetic subjects; the Insulin Resistance Atherosclerosis Study. Diabet Med. 2002 Nov;19(11):939-43. doi: 10.1046/j.1464-5491.2002.00824.x.
    Results Reference
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    PubMed Identifier
    12719278
    Citation
    Festa A, D'Agostino R Jr, Rich SS, Jenny NS, Tracy RP, Haffner SM. Promoter (4G/5G) plasminogen activator inhibitor-1 genotype and plasminogen activator inhibitor-1 levels in blacks, Hispanics, and non-Hispanic whites: the Insulin Resistance Atherosclerosis Study. Circulation. 2003 May 20;107(19):2422-7. doi: 10.1161/01.CIR.0000066908.82782.3A. Epub 2003 Apr 28.
    Results Reference
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    Epidemiology of Impaired Coagulant Balance in Diabetes

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