Cardiovascular DiseasesNCT00005345
Genetic Epidemiology of Blood Lipids and Obesity - Ancillary to NGHS
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1993to Jul 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1993
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Sue Kimm, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005345
- Sponsor's protocol ID
- 4212
- Other IDs
- R01HL045778
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
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. doi: 10.1016/s0022-3476(99)70018-1.
PubMed 10431110Sanghera 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. doi: 10.1016/0021-9150(96)05891-1.
PubMed 8879432Hagberg JM, Moore GE, Ferrell RE. Specific genetic markers of endurance performance and VO2max. Exerc Sport Sci Rev. 2001;29(1):15-9. doi: 10.1097/00003677-200101000-00004.
PubMed 11210441Moffett 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. doi: 10.1007/s00439-002-0715-5. Epub 2002 Apr 4.
PubMed 12073010
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Blood Lipids and Obesity - Ancillary to NGHS
- ClinicalTrials.gov ID
- NCT00005345
- Acronym / sponsor ID
- 4212
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1993
- Study completion
- Jul 2000 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 10431110Kimm 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. doi: 10.1016/s0022-3476(99)70018-1.
- Background: PubMed 8879432Sanghera 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. doi: 10.1016/0021-9150(96)05891-1.
- Background: PubMed 11210441Hagberg JM, Moore GE, Ferrell RE. Specific genetic markers of endurance performance and VO2max. Exerc Sport Sci Rev. 2001;29(1):15-9. doi: 10.1097/00003677-200101000-00004.
- Background: PubMed 12073010Moffett 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. doi: 10.1007/s00439-002-0715-5. Epub 2002 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Kimm
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005345, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.