search
Back to results

Diet, Insulin Resistance, and Cardiovascular Risk

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Insulin Resistance

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of South Carolina
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 10, 2016
    Sponsor
    University of South Carolina
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00005530
    Brief Title
    Diet, Insulin Resistance, and Cardiovascular Risk
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2000 (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in conjunction with insulin resistance.
    Detailed Description
    BACKGROUND: Clinical studies indicate that high carbohydrate intake may exacerbate the dyslipidemia often seen with insulin resistance. Consequently, there is much debate as to the optimal dietary pattern for individuals with NIDDM to minimize risk for microvascular disease. Data on this topic from free-living populations are scarce. In addition, associations of dietary antioxidants with CVD risk have not been evaluated in large community samples of persons with diabetes. DESIGN NARRATIVE: Potential dietary determinants of hyperinsulinemia or of insulin resistance were evaluated, including high intake of dietary fats and of simple sugars and low alcohol consumption. As a major focus, dietary factors that may contribute to elevated CVD risk among persons with existing insulin resistance, including impaired glucose tolerance (IGT) and non-insulin-dependent diabetes mellitus (NIDDM) were examined. Five datasets from epidemiologic studies were available to evaluate specific hypotheses for men and women of Black, Hispanic and non-Hispanic white ethnicity. The unique contributions of each dataset were as follows. The San Luis Valley Diabetes Study and the San Antonio Heart Study enabled prospective analyses for large numbers of subjects with IGT or NIDDM; the Mexico City Study provided a sample with contrasting dietary patterns in a non-white population; the Kaiser Permanente Women Twins Study allowed for the removal of genetic influences by evaluating associations within monozygotic twin pairs; and the Insulin Resistance Atherosclerosis Study (IRAS) provided direct measurement of insulin sensitivity and subclinical atherosclerosis across the spectrum of glucose tolerance in three ethnic groups. An understanding of the accuracy of the dietary assessment instruments used in the three ethnic groups was critical to the interpretation of the findings related to diet and CVD risk variables. Therefore, a second component of research was also conducted, that being an evaluation of the comparative validity of the food frequency interview used in the multi- cultural IRAS population using a series of 24-hour dietary recalls as the standard.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Insulin Resistance, Hyperinsulinism, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus

    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
    Elizabeth Mayer-Davis
    Organizational Affiliation
    University of South Carolina

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10526727
    Citation
    Mayer-Davis EJ, Levin S, Marshall JA. Heterogeneity in associations between macronutrient intake and lipoprotein profile in individuals with type 2 diabetes. Diabetes Care. 1999 Oct;22(10):1632-9. doi: 10.2337/diacare.22.10.1632.
    Results Reference
    background
    PubMed Identifier
    9144749
    Citation
    Mayer-Davis EJ, Monaco JH, Marshall JA, Rushing J, Juhaeri. Vitamin C intake and cardiovascular disease risk factors in persons with non-insulin-dependent diabetes mellitus. From the Insulin Resistance Atherosclerosis Study and the San Luis Valley Diabetes Study. Prev Med. 1997 May-Jun;26(3):277-83. doi: 10.1006/pmed.1997.0145.
    Results Reference
    background
    PubMed Identifier
    8633616
    Citation
    Mayer EJ, Newman B, Austin MA, Zhang D, Quesenberry CP Jr, Edwards K, Selby JV. Genetic and environmental influences on insulin levels and the insulin resistance syndrome: an analysis of women twins. Am J Epidemiol. 1996 Feb 15;143(4):323-32. doi: 10.1093/oxfordjournals.aje.a008746.
    Results Reference
    background
    PubMed Identifier
    11092284
    Citation
    Bell RA, Mayer-Davis EJ, Martin MA, D'Agostino RB Jr, Haffner SM. Associations between alcohol consumption and insulin sensitivity and cardiovascular disease risk factors: the Insulin Resistance and Atherosclerosis Study. Diabetes Care. 2000 Nov;23(11):1630-6. doi: 10.2337/diacare.23.11.1630.
    Results Reference
    background

    Learn more about this trial

    Diet, Insulin Resistance, and Cardiovascular Risk

    We'll reach out to this number within 24 hrs