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Longitudinal LDL-C Studies in Black and White Families

Primary Purpose

Cardiovascular Diseases, Atherosclerosis

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)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00007384
    Brief Title
    Longitudinal LDL-C Studies in Black and White Families
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To longitudinally investigate multigenerational familial clustering of plasma low density lipoprotein cholesterol (LDL-C), with particular emphasis on the influences of apoE genotypes and various 'behaviors'.
    Detailed Description
    BACKGROUND: Elevated concentrations of plasma low density lipoprotein cholesterol (LDL-C), a major risk factor for coronary heart disease, cluster significantly in families. This clustering has been observed in cross-sectional studies in both black and white families, but longitudinal data on the familial clustering of LDL-C are virtually nonexistent. DESIGN NARRATIVE: The longitudinal study will provide new and important information about changes in the familial low density lipoprotein cholesterol (LDL-C) correlations in black and white families from the period of shared household environments to that of separate households, using families from the Princeton Lipid Research Clinics (LRC) Prevalence (1973-75) and Family Studies (1975-76). The study will also provide important information on changes in individual LDL-C levels over the same 25 year period. The former student participants were six to 18 years of age and are now 32 to 45 years of age; their parents were (largely) 26 to 55 years of age and are now 51 to 80 years of age. Plasma LDL-C concentrations in children and adults have been shown to associate with the apolipoprotein (apo) E genotype, with obesity, and with such elective behaviors as diet, cigarette smoking, and physical activity. In the LRC Study, measurements were made of LDL-C, body habitus, elective behaviors, and the family history of cardiovascular disease (CVD). The study will obtain repeat measures of these factors, plus determine the apo E isoforms. Changes in individual LDL-C levels and in familial associations can then be assessed in association with apo E isoforms, body composition, elective behaviors, and family history of CVD. Family members share ranges of body weight, patterns of fat distribution, dietary and smoking habits, and physical activity levels. The extent to which the familial clustering of LDL-C levels is determined by apo E isoforms interacting with the similar levels of obesity, and with the similar behaviors, is not currently known.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Atherosclerosis

    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
    John Morrison
    Organizational Affiliation
    Children's Hospital & Medical Center

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15313151
    Citation
    Miles MV, Horn PS, Tang PH, Morrison JA, Miles L, DeGrauw T, Pesce AJ. Age-related changes in plasma coenzyme Q10 concentrations and redox state in apparently healthy children and adults. Clin Chim Acta. 2004 Sep;347(1-2):139-44. doi: 10.1016/j.cccn.2004.04.003.
    Results Reference
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    PubMed Identifier
    15149886
    Citation
    Miles MV, Morrison JA, Horn PS, Tang PH, Pesce AJ. Coenzyme Q10 changes are associated with metabolic syndrome. Clin Chim Acta. 2004 Jun;344(1-2):173-9. doi: 10.1016/j.cccn.2004.02.016.
    Results Reference
    background
    PubMed Identifier
    12763289
    Citation
    Miles MV, Horn PS, Morrison JA, Tang PH, DeGrauw T, Pesce AJ. Plasma coenzyme Q10 reference intervals, but not redox status, are affected by gender and race in self-reported healthy adults. Clin Chim Acta. 2003 Jun;332(1-2):123-32. doi: 10.1016/s0009-8981(03)00137-2.
    Results Reference
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    Longitudinal LDL-C Studies in Black and White Families

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