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Risk Factors for Atherogenesis in Type 1 Diabetes

Primary Purpose

Atherosclerosis, Cardiovascular Diseases, Diabetes Mellitus, Insulin-dependent

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis

Eligibility Criteria

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

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2002
    Last Updated
    January 28, 2016
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00035750
    Brief Title
    Risk Factors for Atherogenesis in Type 1 Diabetes
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine risk factors for atherogenesis in Type 1 diabetes.
    Detailed Description
    BACKGROUND: Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease (ASVD) than the general population. Risk factors for the development of ASVD have been identified, but linking them to initiation of atherosclerosis was not feasible until recently. Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure. This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD. DESIGN NARRATIVE: Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis. Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank. Because incident cases were enrolled, information was collected from diagnosis on children, adolescents and young adults currently without symptoms of atherosclerosis. The existing database was expanded, the existing resources were used including the plasma bank, and promising new and well established clinical research techniques were incorporated by: (i) measuring plasma lipid levels on stored plasma and on newly collected blood samples, (ii) measuring triglyceride levels on newly collected blood samples, (iii) measuring urinary albumin excretion rates on newly collected specimens (already measured from diagnosis to date), and (iv) assessing endothelial function by brachial artery ultrasound, (v) measuring the intima medial thickness (IMT) of the carotid artery by ultrasound, and (vi) measuring coronary calcium by computed tomography scanning. These activities allowed pursuit of the following specific aims: 1) to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis, 2) to determine the relationship between endothelial dysfunction and carotid IMT, and 3) to determine the relationship between coronary artery calcification and carotid IMT. Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis, Cardiovascular Diseases, Diabetes Mellitus, Insulin-dependent, Heart Diseases, Diabetes Mellitus

    7. Study Design

    10. Eligibility

    Sex
    All
    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
    Mari Palta
    Organizational Affiliation
    University of Wisconsin, Madison

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15746714
    Citation
    Stein JH, Korcarz CE, Mays ME, Douglas PS, Palta M, Zhang H, Lecaire T, Paine D, Gustafson D, Fan L. A semiautomated ultrasound border detection program that facilitates clinical measurement of ultrasound carotid intima-media thickness. J Am Soc Echocardiogr. 2005 Mar;18(3):244-51. doi: 10.1016/j.echo.2004.12.002.
    Results Reference
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    Risk Factors for Atherogenesis in Type 1 Diabetes

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