Longitudinal LDL-C Studies in Black and White Families
Primary Purpose
Cardiovascular Diseases, Atherosclerosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00007384
First Posted
December 19, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
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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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