Cardiovascular DiseasesHERITAGENCT00005137
Heritage Study--Genetics, Exercise and Risk Factors
A study testing exercise program in people with Cardiovascular Diseases and Heart Diseases, run by Washington University School of Medicine.
Trial summary
To document the role of the genotype in the cardiovascular and metabolic responses to aerobic exercise-training and the contribution of inherited factors in the changes brought about by regular exercise for several cardiovascular disease and diabetes risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent
- What is being tested?
- exercise program
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1992to Aug 2005
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
Official title: Health, Risk Factors, Exercise Training, and Genetics
To document the role of the genotype in the cardiovascular and metabolic responses to aerobic exercise-training and the contribution of inherited factors in the changes brought about by regular exercise for several cardiovascular disease and diabetes risk factors. A consortium of laboratories from five institutions in the United States and Canada are carrying out this study.
Read the detailed description
BACKGROUND:
This research should increase our understanding of human variation, the genetics of adaptation to exercise-training and of the concomitant changes in cardiovascular disease and diabetes risk factors.
DESIGN NARRATIVE:
A total of 742 sedentary subjects were recruited, initially tested, exercise-trained in the laboratory with the same program for 20 weeks, and re-tested. The subjects came from families of Caucasian descent with both parents and three biological adult offspring and families of African-American ancestry. Oxygen uptake, expiratory volume and respiratory exchange ratio, blood pressure, heart rate, blood lactate, glucose, glycerol and free-fatty acids, stroke volume and cardiac output were measured during exercise before and after training and maximal oxygen uptake was determined. Plasma lipids, lipoproteins and apoproteins, glucose tolerance and insulin response to an intravenous glucose load, plasma sex steroids and glucocorticoids, resting systolic and diastolic blood pressures, and body fat and regional fat distribution were also assessed. Dietary habits, level of habitual physical activity and other lifestyle components were assessed by questionnaires. Genetic analyses included the determination of the heritability level for each phenotype and its response to regular exercise, testing for the presence of paternal or maternal effects, sex-limited effects, major gene effects and segregation patterns. Multivariate genetic analyses and complex segregation analyses were used to develop hypotheses concerning the genetic basis of the response to exercise-training.
The study was renewed in September 1997 to perform analyses of the data collected under Phase I. A series of nongenetic studies were undertaken on the dataset. Physiological, behavioral, and social determinants of maximal and submaximal indicators of cardiorespiratory endurance in the sedentary state and in the response to training were investigated taking into account the contributions of age, gender, and race. Similar analyses were conducted on the cardiovascular disease and non-insulin dependent diabetes mellitus (NIDDM) risk factors monitored in the study. Genetic analyses determined the heritability levels and tested for paternal or maternal effects, major gene effects, and segregation patterns which were used to develop hypotheses concerning genetic bases of the response to endurance exercise. A panel of candidate genes were typed and used for association and linkage studies. Differential display analysis of skeletal muscle transcripts were used to identify new candidate genes for the response to endurance exercise. Finally, a genome wide search was undertaken to isolate candidate genomic regions and positional candidate genes for the response of cardiorespiratory endurance and cardiovascular and NIDDM risk factor phenotypes.
The study was renewed in 2001 for four years to continue analyses of the data.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- Being tested
- exercise program
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise programOther
subjects were measured before and after a 20-week long on-site exercise training program
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 startJul 1992
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (131)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 Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Claude Bouchard, LSU Pennington Biomedical Research CenterArthur Leon, University of MinnesotaDabeeru Rao, Washington University School of MedicineJames Skinner, Indiana UniversityJack Wilmore, Texas A & M Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005137
- Sponsor's protocol ID
- 1007
- Other IDs
- R01HL047317
- Acronym
- HERITAGE
- Status last verified
- May 2014
- First submitted
- 25 May 2000
- Last updated
- 29 May 2014
- Results posted
- No
Publications
Todorov AA, Borecki IB, Rao DC. Linkage analysis of complex traits using affected sibpairs: effects of single-locus approximations on estimates of the required sample size. Genet Epidemiol. 1997;14(4):389-401. doi: 10.1002/(SICI)1098-2272(1997)14:43.0.CO;2-Z.
PubMed 9271711Todorov AA, Province MA, Borecki IB, Rao DC. Trade-off between sibship size and sampling scheme for detecting quantitative trait loci. Hum Hered. 1997 Jan-Feb;47(1):1-5. doi: 10.1159/000154381.
PubMed 9017972Gu C, Todorov A, Rao DC. Combining extremely concordant sibpairs with extremely discordant sibpairs provides a cost effective way to linkage analysis of quantitative trait loci. Genet Epidemiol. 1996;13(6):513-33. doi: 10.1002/(SICI)1098-2272(1996)13:63.0.CO;2-1.
PubMed 8968712Bouchard C, Leon AS, Rao DC, Skinner JS, Wilmore JH, Gagnon J. The HERITAGE family study. Aims, design, and measurement protocol. Med Sci Sports Exerc. 1995 May;27(5):721-9.
PubMed 7674877Li Z. A multiplicative random effects model for meta-analysis with application to estimation of admixture component. Biometrics. 1995 Sep;51(3):864-73.
PubMed 7548705Li Z, Bonney GE, Lathrop GM, Rao DC. Genetic analysis combining path analysis with regressive models: the TAU model of multifactorial transmission. Hum Hered. 1994 Nov-Dec;44(6):305-11. doi: 10.1159/000154236.
PubMed 7860082Rivera MA, Dionne FT, Simoneau JA, Perusse L, Chagnon M, Chagnon Y, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Muscle-specific creatine kinase gene polymorphism and VO2max in the HERITAGE Family Study. Med Sci Sports Exerc. 1997 Oct;29(10):1311-7. doi: 10.1097/00005768-199710000-00006.
PubMed 9346161Gu C, Borecki I, Gagnon J, Bouchard C, Leon AS, Skinner JS, Wilmore JH, Rao DC. Familial resemblance for resting blood pressure with particular reference to racial differences: preliminary analyses from the HERITAGE Family Study. Hum Biol. 1998 Feb;70(1):77-90.
PubMed 9489236Daw EW, Province MA, Gagnon J, Despres JP, Bouchard C, Leon AS, Skinner JS, Wilmore JH, Rao DC. Reproducibility of the HERITAGE Family Study intervention protocol: drift over time. Ann Epidemiol. 1997 Oct;7(7):452-62. doi: 10.1016/s1047-2797(97)00082-3.
PubMed 9349912Gagnon J, Ho-Kim MA, Chagnon YC, Perusse L, Dionne T, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Absence of linkage between VO2max and its response to training with markers spanning chromosome 22. Med Sci Sports Exerc. 1997 Nov;29(11):1448-53. doi: 10.1097/00005768-199711000-00010.
PubMed 9372481Perusse L, Rice T, Despres JP, Bergeron J, Province MA, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Familial resemblance of plasma lipids, lipoproteins and postheparin lipoprotein and hepatic lipases in the HERITAGE Family Study. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):3263-9. doi: 10.1161/01.atv.17.11.3263.
PubMed 9409321An P, Rice T, Gagnon J, Hong Y, Leon AS, Skinner JS, Wilmore JH, Bouchard C, Rao DC. A genetic study of dehydroepiandrosterone sulfate measured before and after a 20-week endurance exercise training program: the HERITAGE Family Study. Metabolism. 2000 Mar;49(3):298-304. doi: 10.1016/s0026-0495(00)90044-1.
PubMed 10726904Wilmore JH, Stanforth PR, Gagnon J, Leon AS, Rao DC, Skinner JS, Bouchard C. Endurance exercise training has a minimal effect on resting heart rate: the HERITAGE Study. Med Sci Sports Exerc. 1996 Jul;28(7):829-35. doi: 10.1097/00005768-199607000-00009.
PubMed 8832536Gagnon J, Province MA, Bouchard C, Leon AS, Skinner JS, Wilmore JH, Rao DC. The HERITAGE Family Study: quality assurance and quality control. Ann Epidemiol. 1996 Nov;6(6):520-9. doi: 10.1016/s1047-2797(96)00068-3.
PubMed 8978882Couillard C, Gagnon J, Bergeron J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Despres JP, Bouchard C. Contribution of body fatness and adipose tissue distribution to the age variation in plasma steroid hormone concentrations in men: the HERITAGE Family Study. J Clin Endocrinol Metab. 2000 Mar;85(3):1026-31. doi: 10.1210/jcem.85.3.6427.
PubMed 10720034
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health, Risk Factors, Exercise Training, and Genetics
- ClinicalTrials.gov ID
- NCT00005137
- Acronym / sponsor ID
- HERITAGE / 1007
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1992
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (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 document the role of the genotype in the cardiovascular and metabolic responses to aerobic exercise-training and the contribution of inherited factors in the changes brought about by regular exercise for several cardiovascular disease and diabetes risk factors. A consortium of laboratories from five institutions in the United States and Canada are carrying out this study.
Detailed description
BACKGROUND:
This research should increase our understanding of human variation, the genetics of adaptation to exercise-training and of the concomitant changes in cardiovascular disease and diabetes risk factors.
DESIGN NARRATIVE:
A total of 742 sedentary subjects were recruited, initially tested, exercise-trained in the laboratory with the same program for 20 weeks, and re-tested. The subjects came from families of Caucasian descent with both parents and three biological adult offspring and families of African-American ancestry. Oxygen uptake, expiratory volume and respiratory exchange ratio, blood pressure, heart rate, blood lactate, glucose, glycerol and free-fatty acids, stroke volume and cardiac output were measured during exercise before and after training and maximal oxygen uptake was determined. Plasma lipids, lipoproteins and apoproteins, glucose tolerance and insulin response to an intravenous glucose load, plasma sex steroids and glucocorticoids, resting systolic and diastolic blood pressures, and body fat and regional fat distribution were also assessed. Dietary habits, level of habitual physical activity and other lifestyle components were assessed by questionnaires. Genetic analyses included the determination of the heritability level for each phenotype and its response to regular exercise, testing for the presence of paternal or maternal effects, sex-limited effects, major gene effects and segregation patterns. Multivariate genetic analyses and complex segregation analyses were used to develop hypotheses concerning the genetic basis of the response to exercise-training.
The study was renewed in September 1997 to perform analyses of the data collected under Phase I. A series of nongenetic studies were undertaken on the dataset. Physiological, behavioral, and social determinants of maximal and submaximal indicators of cardiorespiratory endurance in the sedentary state and in the response to training were investigated taking into account the contributions of age, gender, and race. Similar analyses were conducted on the cardiovascular disease and non-insulin dependent diabetes mellitus (NIDDM) risk factors monitored in the study. Genetic analyses determined the heritability levels and tested for paternal or maternal effects, major gene effects, and segregation patterns which were used to develop hypotheses concerning genetic bases of the response to endurance exercise. A panel of candidate genes were typed and used for association and linkage studies. Differential display analysis of skeletal muscle transcripts were used to identify new candidate genes for the response to endurance exercise. Finally, a genome wide search was undertaken to isolate candidate genomic regions and positional candidate genes for the response of cardiorespiratory endurance and cardiovascular and NIDDM risk factor phenotypes.
The study was renewed in 2001 for four years to continue analyses of the data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Sex
- All
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise programsubjects were measured before and after a 20-week long on-site exercise training program | Other | – |
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 29 May 2014.
- Background: PubMed 9271711Todorov AA, Borecki IB, Rao DC. Linkage analysis of complex traits using affected sibpairs: effects of single-locus approximations on estimates of the required sample size. Genet Epidemiol. 1997;14(4):389-401. doi: 10.1002/(SICI)1098-2272(1997)14:43.0.CO;2-Z.
- Background: PubMed 9017972Todorov AA, Province MA, Borecki IB, Rao DC. Trade-off between sibship size and sampling scheme for detecting quantitative trait loci. Hum Hered. 1997 Jan-Feb;47(1):1-5. doi: 10.1159/000154381.
- Background: PubMed 8968712Gu C, Todorov A, Rao DC. Combining extremely concordant sibpairs with extremely discordant sibpairs provides a cost effective way to linkage analysis of quantitative trait loci. Genet Epidemiol. 1996;13(6):513-33. doi: 10.1002/(SICI)1098-2272(1996)13:63.0.CO;2-1.
- Background: PubMed 7674877Bouchard C, Leon AS, Rao DC, Skinner JS, Wilmore JH, Gagnon J. The HERITAGE family study. Aims, design, and measurement protocol. Med Sci Sports Exerc. 1995 May;27(5):721-9.
- Background: PubMed 7548705Li Z. A multiplicative random effects model for meta-analysis with application to estimation of admixture component. Biometrics. 1995 Sep;51(3):864-73.
- Background: PubMed 7860082Li Z, Bonney GE, Lathrop GM, Rao DC. Genetic analysis combining path analysis with regressive models: the TAU model of multifactorial transmission. Hum Hered. 1994 Nov-Dec;44(6):305-11. doi: 10.1159/000154236.
- Background: PubMed 9346161Rivera MA, Dionne FT, Simoneau JA, Perusse L, Chagnon M, Chagnon Y, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Muscle-specific creatine kinase gene polymorphism and VO2max in the HERITAGE Family Study. Med Sci Sports Exerc. 1997 Oct;29(10):1311-7. doi: 10.1097/00005768-199710000-00006.
- Background: PubMed 9489236Gu C, Borecki I, Gagnon J, Bouchard C, Leon AS, Skinner JS, Wilmore JH, Rao DC. Familial resemblance for resting blood pressure with particular reference to racial differences: preliminary analyses from the HERITAGE Family Study. Hum Biol. 1998 Feb;70(1):77-90.
- Background: PubMed 9349912Daw EW, Province MA, Gagnon J, Despres JP, Bouchard C, Leon AS, Skinner JS, Wilmore JH, Rao DC. Reproducibility of the HERITAGE Family Study intervention protocol: drift over time. Ann Epidemiol. 1997 Oct;7(7):452-62. doi: 10.1016/s1047-2797(97)00082-3.
- Background: PubMed 9372481Gagnon J, Ho-Kim MA, Chagnon YC, Perusse L, Dionne T, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Absence of linkage between VO2max and its response to training with markers spanning chromosome 22. Med Sci Sports Exerc. 1997 Nov;29(11):1448-53. doi: 10.1097/00005768-199711000-00010.
- Background: PubMed 9409321Perusse L, Rice T, Despres JP, Bergeron J, Province MA, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Familial resemblance of plasma lipids, lipoproteins and postheparin lipoprotein and hepatic lipases in the HERITAGE Family Study. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):3263-9. doi: 10.1161/01.atv.17.11.3263.
- Background: PubMed 10726904An P, Rice T, Gagnon J, Hong Y, Leon AS, Skinner JS, Wilmore JH, Bouchard C, Rao DC. A genetic study of dehydroepiandrosterone sulfate measured before and after a 20-week endurance exercise training program: the HERITAGE Family Study. Metabolism. 2000 Mar;49(3):298-304. doi: 10.1016/s0026-0495(00)90044-1.
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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.
Claude Bouchard
LSU Pennington Biomedical Research Center
Arthur Leon
University of Minnesota
Dabeeru Rao
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing exercise program in people with Cardiovascular Diseases and Heart Diseases, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. 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 NCT00005137, which also lists 131 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 29 May 2014.