Cardiovascular DiseasesNCT00005462
Genetics of Atherosclerosis in Mexican Americans
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify individual genes that contribute to variation in susceptibility to coronary heart disease (CHD) in Mexican Americans. The program project grant supports the San Antonio Family Heart Study, the first comprehensive genetic epidemiological study of atherosclerosis and its correlates in Mexican Americans. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to May 2008
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify individual genes that contribute to variation in susceptibility to coronary heart disease (CHD) in Mexican Americans. The program project grant supports the San Antonio Family Heart Study, the first comprehensive genetic epidemiological study of atherosclerosis and its correlates in Mexican Americans.
Read the detailed description
DESIGN NARRATIVE:
The study, which began in 1991, focuses on genes that influence the lipoprotein profile in members of randomly ascertained Mexican-American families, with particular emphasis on genetic effects on reverse cholesterol transport. An overall objective is to investigate the pleiotropic effects of these "lipoprotein genes" and their interactions with genes that affect non-insulin dependent diabetes mellitus (NIDDM) antecedents and body fat distribution. The interactions of lipoprotein genes with sex hormonal status and with environmental risk factors such as diet, exercise, and smoking are investigated. Genetic effects on standard lipoprotein variables are examined, e.g. plasma concentrations of lipoproteins and apolipoproteins. Several novel lipoprotein phenotypes also are analyzed, e.g. amounts of esterified and unesterified cholesterol and of specific apolipoproteins in lipoprotein subclasses. Molecular, biochemical, and statistical genetic approaches are used to detect, localize and characterize genes that influence quantitative phenotypes associated with lipoproteins, NIDDM, and obesity, and to quantify the effects of known candidate loci on these phenotypes.
The study was renewed in 1997. The subprojects as described in the summary statement are as follows.
In Project 1, gene mapping is performed on genes that influence quantitative phenotypes related to the development of atherosclerosis in Mexican American families in the San Antonio Family Heart Study. A genomic search using a 10 centimorgan map of 3 91 short tandem report markers distributed throughout the genome is used to determine the chromosomal location of six major genes influencing HDL cholesterol, LDL cholesterol, apo A1, apob, SHBC, and DHEAS. Evidence for major gene effects is sought for lipoprotein phenotypes for which no major genes have yet been detected. Genetic effects on carotid and fibrinolysis phenotypes are quantified using data from a recall of 750 family members. Full pedigree variance component analysis as well as penetrance-based methods are used in a genomic search to determine the chromosomal locations of genes that influence these phenotypes. To improve genetic models, strengthen evidence for linkage, and reduce the number of false positives, GxE interactions and pleiotropic and epistatic effects of major genes are quantified.
In Project 2, a genome-wide search is carried out to localize genes that contribute to quantitative variation in traits related to atherosclerosis, NIDDM, and obesity. The first, primary task is the genotyping of some 1,400 pedigree members for 391 short tandem repeat (STR) markers using semi-automated, fluorescence based genotyping on an ABI automatic sequencer. When statistical evidence of linkage has been evaluated in Projects 1 and 3 and confirmed, "additional STRs" will be typed in the region to further localize the gene. The initial map will have a 10 centimorgan resolution. Multipoint linkage analysis and gametic disequilibrium analysis will be used to further localize the region containing the gene of interest. The human gene map will then be consulted to identify candidate genes in the region, and these genes will be subjected to a more detailed molecular analysis to identify structural or functional differences that underlie the observed allelic effects.
In Project 3, genetic determinants of NIDDM and obesity are determined and the effects of these genes are specified on lipoproteins, carotid wall thickness, and other phenotypes pertaining to cardiovascular risk.
Core A, Field and Clinical Operations has five aims. The first is to reexamine 750 of the original study participants near the sixth anniversary of their baseline exam. The second is to update demographic information, medical history, physical activity and dietary habits. The third aim is to perform an oral glucose tolerance test with insulin measurement and to obtain fasting blood specimens for other projects and labs. The fourth is to perform B-mode ultrasonography exams of the internal carotid artery. The fifth is to construct a computerized data file containing these data.
Core B, Computing and Data Management, provides database management for genotypic/phenotypic data, for clinical and interview data, and for pedigrees based on these data.
Core C, Clinical Phenotypes and Resources, performs analyses to measure LDL particle sizes in the frozen samples from the original 1,588 samples, measures LP(A) concentrations and performs apo(a) phenotyping in the recall samples, measures plasma lipids and HDL cholesterol in the recall samples, and contracts for measurement of fibrinolytic endpoints in the recall sample.
Core D is the Administation Core.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Obesity, Atherosclerosis, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Obesity, Atherosclerosis, Diabetes Mellitus, Type 2, Diabetes Mellitus
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 startSep 1991
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (104)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
- Jean MacCluer, Southwest Foundation for Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005462
- Sponsor's protocol ID
- 4906
- Other IDs
- P01HL045522-14
- Status last verified
- Jul 2008
- First submitted
- 25 May 2000
- Last updated
- 12 Jul 2016
- Results posted
- No
Publications
Mitchell BD, Blangero J, Comuzzie AG, Almasy LA, Shuldiner AR, Silver K, Stern MP, MacCluer JW, Hixson JE. A paired sibling analysis of the beta-3 adrenergic receptor and obesity in Mexican Americans. J Clin Invest. 1998 Feb 1;101(3):584-7. doi: 10.1172/JCI512.
PubMed 9449691MacCluer JW, Blangero J, Dyer TD, Speer MC. GAW10: simulated family data for a common oligogenic disease with quantitative risk factors. Genet Epidemiol. 1997;14(6):737-42. doi: 10.1002/(SICI)1098-2272(1997)14:63.0.CO;2-Q.
PubMed 9433570Mitchell BD, Kammerer CM, Blangero J, Mahaney MC, Rainwater DL, Dyke B, Hixson JE, Henkel RD, Sharp RM, Comuzzie AG, VandeBerg JL, Stern MP, MacCluer JW. Genetic and environmental contributions to cardiovascular risk factors in Mexican Americans. The San Antonio Family Heart Study. Circulation. 1996 Nov 1;94(9):2159-70. doi: 10.1161/01.cir.94.9.2159.
PubMed 8901667MacCluer JW, Blangero J, Dyer TD, Kammerer CM. Simulation of a common oligogenic disease with quantitative risk factors. GAW9 problem 2: the answers. Genet Epidemiol. 1995;12(6):707-12. doi: 10.1002/gepi.1370120629.
PubMed 8787996Blangero J, Williams-Blangero S, Mahaney MC, Comuzzie AG, Hixson JE, Samollow PB, Sharp RM, Stern MP, MacCluer JW. Effects of a major gene for apolipoprotein A-I concentration are thyroid hormone dependent in Mexican Americans. Arterioscler Thromb Vasc Biol. 1996 Sep;16(9):1177-83. doi: 10.1161/01.atv.16.9.1177.
PubMed 8792772Mitchell BD, Kammerer CM, Mahaney MC, Blangero J, Comuzzie AG, Atwood LD, Haffner SM, Stern MP, MacCluer JW. Genetic analysis of the IRS. Pleiotropic effects of genes influencing insulin levels on lipoprotein and obesity measures. Arterioscler Thromb Vasc Biol. 1996 Feb;16(2):281-8. doi: 10.1161/01.atv.16.2.281.
PubMed 8620344Mitchell BD, Kammerer CM, Reinhart LJ, Stern MP, MacCluer JW. Is there an excess in maternal transmission of NIDDM? Diabetologia. 1995 Mar;38(3):314-7. doi: 10.1007/BF00400636.
PubMed 7758878Mitchell BD, Kammerer CM, Hixson JE, Atwood LD, Hackleman S, Blangero J, Haffner SM, Stern MP, MacCluer JW. Evidence for a major gene affecting postchallenge insulin levels in Mexican-Americans. Diabetes. 1995 Mar;44(3):284-9. doi: 10.2337/diab.44.3.284.
PubMed 7883115Duggirala R, Gonzalez Villalpando C, O'Leary DH, Stern MP, Blangero J. Genetic basis of variation in carotid artery wall thickness. Stroke. 1996 May;27(5):833-7. doi: 10.1161/01.str.27.5.833.
PubMed 8623101Haffner SM, Miettinen H, Mykkanen L, Karhapaa P, Rainwater DL, Laakso M. Leptin concentrations and insulin sensitivity in normoglycemic men. Int J Obes Relat Metab Disord. 1997 May;21(5):393-9. doi: 10.1038/sj.ijo.0800419.
PubMed 9152742Mitchell BD, Atwood LD, Reinhart L. The influence of response bias on segregation and linkage analysis. Genet Epidemiol. 1995;12(6):795-9. doi: 10.1002/gepi.1370120644.
PubMed 8788011Rainwater DL, MacCluer JW, Stern MP, VandeBerg JL, Haffner SM. Effects of NIDDM on lipoprotein(a) concentration and apolipoprotein(a) size. Diabetes. 1994 Jul;43(7):942-6. doi: 10.2337/diab.43.7.942.
PubMed 8013760Haffner SM, Frangos M, Williamson J, Santiago J, Valdez R, Aldrete G, Mykkanen L, Gruber KK, Rainwater DL. Lp(a) concentrations and phenotypes in children with insulin-dependent diabetes mellitus. Chem Phys Lipids. 1994 Jan;67-68:223-31. doi: 10.1016/0009-3084(94)90141-4.
PubMed 8187217Aiello RJ, Nevin DN, Ebert DL, Uelmen PJ, Kaiser ME, MacCluer JW, Blangero J, Dyer TD, Attie AD. Apolipoprotein B and a second major gene locus contribute to phenotypic variation of spontaneous hypercholesterolemia in pigs. Arterioscler Thromb. 1994 Mar;14(3):409-19. doi: 10.1161/01.atv.14.3.409.
PubMed 8123646Atwood LD, Kammerer CM, Mitchell BD. Exploring the HDL likelihood surface. Genet Epidemiol. 1993;10(6):641-5. doi: 10.1002/gepi.1370100652.
PubMed 8314074
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Atherosclerosis in Mexican Americans
- ClinicalTrials.gov ID
- NCT00005462
- Acronym / sponsor ID
- 4906
- Conditions
- Cardiovascular Diseases, Coronary Disease, Obesity, Atherosclerosis, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (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 identify individual genes that contribute to variation in susceptibility to coronary heart disease (CHD) in Mexican Americans. The program project grant supports the San Antonio Family Heart Study, the first comprehensive genetic epidemiological study of atherosclerosis and its correlates in Mexican Americans.
Detailed description
DESIGN NARRATIVE:
The study, which began in 1991, focuses on genes that influence the lipoprotein profile in members of randomly ascertained Mexican-American families, with particular emphasis on genetic effects on reverse cholesterol transport. An overall objective is to investigate the pleiotropic effects of these "lipoprotein genes" and their interactions with genes that affect non-insulin dependent diabetes mellitus (NIDDM) antecedents and body fat distribution. The interactions of lipoprotein genes with sex hormonal status and with environmental risk factors such as diet, exercise, and smoking are investigated. Genetic effects on standard lipoprotein variables are examined, e.g. plasma concentrations of lipoproteins and apolipoproteins. Several novel lipoprotein phenotypes also are analyzed, e.g. amounts of esterified and unesterified cholesterol and of specific apolipoproteins in lipoprotein subclasses. Molecular, biochemical, and statistical genetic approaches are used to detect, localize and characterize genes that influence quantitative phenotypes associated with lipoproteins, NIDDM, and obesity, and to quantify the effects of known candidate loci on these phenotypes.
The study was renewed in 1997. The subprojects as described in the summary statement are as follows.
In Project 1, gene mapping is performed on genes that influence quantitative phenotypes related to the development of atherosclerosis in Mexican American families in the San Antonio Family Heart Study. A genomic search using a 10 centimorgan map of 3 91 short tandem report markers distributed throughout the genome is used to determine the chromosomal location of six major genes influencing HDL cholesterol, LDL cholesterol, apo A1, apob, SHBC, and DHEAS. Evidence for major gene effects is sought for lipoprotein phenotypes for which no major genes have yet been detected. Genetic effects on carotid and fibrinolysis phenotypes are quantified using data from a recall of 750 family members. Full pedigree variance component analysis as well as penetrance-based methods are used in a genomic search to determine the chromosomal locations of genes that influence these phenotypes. To improve genetic models, strengthen evidence for linkage, and reduce the number of false positives, GxE interactions and pleiotropic and epistatic effects of major genes are quantified.
In Project 2, a genome-wide search is carried out to localize genes that contribute to quantitative variation in traits related to atherosclerosis, NIDDM, and obesity. The first, primary task is the genotyping of some 1,400 pedigree members for 391 short tandem repeat (STR) markers using semi-automated, fluorescence based genotyping on an ABI automatic sequencer. When statistical evidence of linkage has been evaluated in Projects 1 and 3 and confirmed, "additional STRs" will be typed in the region to further localize the gene. The initial map will have a 10 centimorgan resolution. Multipoint linkage analysis and gametic disequilibrium analysis will be used to further localize the region containing the gene of interest. The human gene map will then be consulted to identify candidate genes in the region, and these genes will be subjected to a more detailed molecular analysis to identify structural or functional differences that underlie the observed allelic effects.
In Project 3, genetic determinants of NIDDM and obesity are determined and the effects of these genes are specified on lipoproteins, carotid wall thickness, and other phenotypes pertaining to cardiovascular risk.
Core A, Field and Clinical Operations has five aims. The first is to reexamine 750 of the original study participants near the sixth anniversary of their baseline exam. The second is to update demographic information, medical history, physical activity and dietary habits. The third aim is to perform an oral glucose tolerance test with insulin measurement and to obtain fasting blood specimens for other projects and labs. The fourth is to perform B-mode ultrasonography exams of the internal carotid artery. The fifth is to construct a computerized data file containing these data.
Core B, Computing and Data Management, provides database management for genotypic/phenotypic data, for clinical and interview data, and for pedigrees based on these data.
Core C, Clinical Phenotypes and Resources, performs analyses to measure LDL particle sizes in the frozen samples from the original 1,588 samples, measures LP(A) concentrations and performs apo(a) phenotyping in the recall samples, measures plasma lipids and HDL cholesterol in the recall samples, and contracts for measurement of fibrinolytic endpoints in the recall sample.
Core D is the Administation Core.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male 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 12 Jul 2016.
- Background: PubMed 9449691Mitchell BD, Blangero J, Comuzzie AG, Almasy LA, Shuldiner AR, Silver K, Stern MP, MacCluer JW, Hixson JE. A paired sibling analysis of the beta-3 adrenergic receptor and obesity in Mexican Americans. J Clin Invest. 1998 Feb 1;101(3):584-7. doi: 10.1172/JCI512.
- Background: PubMed 9433570MacCluer JW, Blangero J, Dyer TD, Speer MC. GAW10: simulated family data for a common oligogenic disease with quantitative risk factors. Genet Epidemiol. 1997;14(6):737-42. doi: 10.1002/(SICI)1098-2272(1997)14:63.0.CO;2-Q.
- Background: PubMed 8901667Mitchell BD, Kammerer CM, Blangero J, Mahaney MC, Rainwater DL, Dyke B, Hixson JE, Henkel RD, Sharp RM, Comuzzie AG, VandeBerg JL, Stern MP, MacCluer JW. Genetic and environmental contributions to cardiovascular risk factors in Mexican Americans. The San Antonio Family Heart Study. Circulation. 1996 Nov 1;94(9):2159-70. doi: 10.1161/01.cir.94.9.2159.
- Background: PubMed 8787996MacCluer JW, Blangero J, Dyer TD, Kammerer CM. Simulation of a common oligogenic disease with quantitative risk factors. GAW9 problem 2: the answers. Genet Epidemiol. 1995;12(6):707-12. doi: 10.1002/gepi.1370120629.
- Background: PubMed 8792772Blangero J, Williams-Blangero S, Mahaney MC, Comuzzie AG, Hixson JE, Samollow PB, Sharp RM, Stern MP, MacCluer JW. Effects of a major gene for apolipoprotein A-I concentration are thyroid hormone dependent in Mexican Americans. Arterioscler Thromb Vasc Biol. 1996 Sep;16(9):1177-83. doi: 10.1161/01.atv.16.9.1177.
- Background: PubMed 8620344Mitchell BD, Kammerer CM, Mahaney MC, Blangero J, Comuzzie AG, Atwood LD, Haffner SM, Stern MP, MacCluer JW. Genetic analysis of the IRS. Pleiotropic effects of genes influencing insulin levels on lipoprotein and obesity measures. Arterioscler Thromb Vasc Biol. 1996 Feb;16(2):281-8. doi: 10.1161/01.atv.16.2.281.
- Background: PubMed 7758878Mitchell BD, Kammerer CM, Reinhart LJ, Stern MP, MacCluer JW. Is there an excess in maternal transmission of NIDDM? Diabetologia. 1995 Mar;38(3):314-7. doi: 10.1007/BF00400636.
- Background: PubMed 7883115Mitchell BD, Kammerer CM, Hixson JE, Atwood LD, Hackleman S, Blangero J, Haffner SM, Stern MP, MacCluer JW. Evidence for a major gene affecting postchallenge insulin levels in Mexican-Americans. Diabetes. 1995 Mar;44(3):284-9. doi: 10.2337/diab.44.3.284.
- Background: PubMed 8623101Duggirala R, Gonzalez Villalpando C, O'Leary DH, Stern MP, Blangero J. Genetic basis of variation in carotid artery wall thickness. Stroke. 1996 May;27(5):833-7. doi: 10.1161/01.str.27.5.833.
- Background: PubMed 9152742Haffner SM, Miettinen H, Mykkanen L, Karhapaa P, Rainwater DL, Laakso M. Leptin concentrations and insulin sensitivity in normoglycemic men. Int J Obes Relat Metab Disord. 1997 May;21(5):393-9. doi: 10.1038/sj.ijo.0800419.
- Background: PubMed 8788011Mitchell BD, Atwood LD, Reinhart L. The influence of response bias on segregation and linkage analysis. Genet Epidemiol. 1995;12(6):795-9. doi: 10.1002/gepi.1370120644.
- Background: PubMed 8013760Rainwater DL, MacCluer JW, Stern MP, VandeBerg JL, Haffner SM. Effects of NIDDM on lipoprotein(a) concentration and apolipoprotein(a) size. Diabetes. 1994 Jul;43(7):942-6. doi: 10.2337/diab.43.7.942.
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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.
Jean MacCluer
Southwest Foundation for Biomedical Research
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, 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 12 Jul 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 NCT00005462, which also lists 104 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 12 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.