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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005345
Other study ID # 4212
Secondary ID R01HL045778
Status Completed
Phase N/A
First received May 25, 2000
Last updated May 12, 2016
Start date January 1993
Est. completion date July 2000

Study information

Verified date August 2004
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To conduct a genetic epidemiologic study of the coronary heart disease (CHD) risk factors of blood lipids and obesity in Black and white girls who participated in the NHLBI-supported National Growth and Health Study (NGHS). The study was ancillary to NGHS.


Description:

BACKGROUND:

The National Growth and Health Study, NGHS, was an epidemiologic study of 2,379 black and white girls, ages 9-10 years at entry, who were followed annually. The ancillary study had the potential for identifying those genes involved in determining Black/white differences in lipid metabolism and obesity. This was an exciting area in which there was virtually no available information. Finally, the study permitted an examination of the effects of gene variation on changes in quantitative levels of blood lipids as well as in body fat during different stages of pubescence since the NGHS protocol included annual anthropometric and maturation assessments and biannual blood lipid determinations along with extensive environmental measures which included dietary, household, and psychosocial information. The study was unique because of the rare opportunity to do genetic analyses in a large cohort of two ethnic groups of children on whom a very rich data base was available.

DESIGN NARRATIVE:

The study was an independent research project ancillary to the NGHS and utilized the extensive biological and environmental information available from the NGHS core data base. Blood samples were obtained from 1,133 girls seen at their followup examinations in Year 7 in order to determine genotypes at those loci known to be implicated in lipid metabolism and obesity. Both protein [apolipoproteins C-II, D, and E and LP(a)] and DNA [apolipoprotein B, lipoprotein lipase (LPL), and LDL receptor] were analyzed. The distribution of genetic variation within each ethnic group was determined. At each candidate gene locus, the genotype effects were estimated on quantitative level of apolipoproteins and lipoproteins, and also on the degree and distribution of body fat after adjusting for concomitant variables (such as age, biologic maturation stage adiposity) within each ethnic group. By comparing the frequencies of genotypes at candidate loci, their allelic effects were assessed as well as their impact on blood lipids and obesity development in Black and white females.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date July 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Hagberg JM, Moore GE, Ferrell RE. Specific genetic markers of endurance performance and VO2max. Exerc Sport Sci Rev. 2001;29(1):15-9. Review. — View Citation

Kimm SY, Pasagian-Macaulay A, Aston CE, McAllister AE, Glynn NW, Kamboh MI, Ferrell RE. Correlates of lipoprotein(a) levels in a biracial cohort of young girls: the NHLBI Growth and Health Study. J Pediatr. 1999 Aug;135(2 Pt 1):169-76. — View Citation

Moffett S, Martinson J, Shriver MD, Deka R, McGarvey ST, Barrantes R, Ferrell RE. Genetic diversity and evolution of the human leptin locus tetranucleotide repeat. Hum Genet. 2002 May;110(5):412-7. Epub 2002 Apr 4. — View Citation

Sanghera DK, Ferrell RE, Aston CE, McAllister AE, Kamboh MI, Kimm SY. Quantitative effects of the apolipoprotein E polymorphism in a biracial sample of 9-10-year-old girls. Atherosclerosis. 1996 Sep 27;126(1):35-42. — View Citation

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