Cardiovascular DiseasesNCT00005355
Gender Differences in Familial Risk
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
Trial summary
To develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 1993to Jan 1996
- 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 develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences.
Read the detailed description
DESIGN NARRATIVE:
Models were developed which allowed for sex difference in the expression of autosomal polygenes, differences in the impact of the paternal and maternal environment on male and female offspring, and for the complex consequences of assortative mating on the correlations among loci and between genes and environment. Computer simulations were used to decide which kinds of gender-dependent effects could be resolved with particular constellations of relatives, and to address problems of power and bias resulting from errors of model-specification. The methods developed were applied to data from extensive data already gathered from twins and their relatives to determine the importance of sex differences in genetic and environmental causes of variation in measured aspects of cardiovascular risk including weight, body-mass index, family history of CV disease, smoking, alcohol consumption, exercise, diet, psychosocial variables and lifestyle.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
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 startFeb 1993
- Study completionJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005355
- Sponsor's protocol ID
- 4241
- Other IDs
- R01HL048148
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 2 Mar 2016
- Results posted
- No
Publications
Loos R, Thomis M, Maes HH, Beunen G, Claessens AL, Derom C, Legius E, Derom R, Vlietinck R. Gender-specific regional changes in genetic structure of muscularity in early adolescence. J Appl Physiol (1985). 1997 Jun;82(6):1802-10. doi: 10.1152/jappl.1997.82.6.1802.
PubMed 9173944Thomis MA, Van Leemputte M, Maes HH, Blimkie CJ, Claessens AL, Marchal G, Willems E, Vlietinck RF, Beunen GP. Multivariate genetic analysis of maximal isometric muscle force at different elbow angles. J Appl Physiol (1985). 1997 Mar;82(3):959-67. doi: 10.1152/jappl.1997.82.3.959.
PubMed 9074988Maes HH, Beunen GP, Vlietinck RF, Neale MC, Thomis M, Vanden Eynde B, Lysens R, Simons J, Derom C, Derom R. Inheritance of physical fitness in 10-yr-old twins and their parents. Med Sci Sports Exerc. 1996 Dec;28(12):1479-91. doi: 10.1097/00005768-199612000-00007.
PubMed 8970142Eaves LJ, Neale MC, Maes H. Multivariate multipoint linkage analysis of quantitative trait loci. Behav Genet. 1996 Sep;26(5):519-25. doi: 10.1007/BF02359757.
PubMed 8917951Meyer JM, Han J, Singh R, Moxley G. Sex influences on the penetrance of HLA shared-epitope genotypes for rheumatoid arthritis. Am J Hum Genet. 1996 Feb;58(2):371-83.
PubMed 8571964Neale MC, Eaves LJ, Kendler KS. The power of the classical twin study to resolve variation in threshold traits. Behav Genet. 1994 May;24(3):239-58. doi: 10.1007/BF01067191.
PubMed 7945154Neale MC, Walters EE, Eaves LJ, Maes HH, Kendler KS. Multivariate genetic analysis of twin-family data on fears: Mx models. Behav Genet. 1994 Mar;24(2):119-39. doi: 10.1007/BF01067816.
PubMed 8024529Eaves LJ. Effect of genetic architecture on the power of human linkage studies to resolve the contribution of quantitative trait loci. Heredity (Edinb). 1994 Feb;72 ( Pt 2):175-92. doi: 10.1038/hdy.1994.25.
PubMed 8150657
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Familial Risk
- ClinicalTrials.gov ID
- NCT00005355
- Acronym / sponsor ID
- 4241
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1993
- Study completion
- Jan 1996
- 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 develop, test, and apply comprehensive mathematical models for the interaction of genetic and environmental effect on cardiovascular risk with gender differences.
Detailed description
DESIGN NARRATIVE:
Models were developed which allowed for sex difference in the expression of autosomal polygenes, differences in the impact of the paternal and maternal environment on male and female offspring, and for the complex consequences of assortative mating on the correlations among loci and between genes and environment. Computer simulations were used to decide which kinds of gender-dependent effects could be resolved with particular constellations of relatives, and to address problems of power and bias resulting from errors of model-specification. The methods developed were applied to data from extensive data already gathered from twins and their relatives to determine the importance of sex differences in genetic and environmental causes of variation in measured aspects of cardiovascular risk including weight, body-mass index, family history of CV disease, smoking, alcohol consumption, exercise, diet, psychosocial variables and lifestyle.
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 2 Mar 2016.
- Background: PubMed 9173944Loos R, Thomis M, Maes HH, Beunen G, Claessens AL, Derom C, Legius E, Derom R, Vlietinck R. Gender-specific regional changes in genetic structure of muscularity in early adolescence. J Appl Physiol (1985). 1997 Jun;82(6):1802-10. doi: 10.1152/jappl.1997.82.6.1802.
- Background: PubMed 9074988Thomis MA, Van Leemputte M, Maes HH, Blimkie CJ, Claessens AL, Marchal G, Willems E, Vlietinck RF, Beunen GP. Multivariate genetic analysis of maximal isometric muscle force at different elbow angles. J Appl Physiol (1985). 1997 Mar;82(3):959-67. doi: 10.1152/jappl.1997.82.3.959.
- Background: PubMed 8970142Maes HH, Beunen GP, Vlietinck RF, Neale MC, Thomis M, Vanden Eynde B, Lysens R, Simons J, Derom C, Derom R. Inheritance of physical fitness in 10-yr-old twins and their parents. Med Sci Sports Exerc. 1996 Dec;28(12):1479-91. doi: 10.1097/00005768-199612000-00007.
- Background: PubMed 8917951Eaves LJ, Neale MC, Maes H. Multivariate multipoint linkage analysis of quantitative trait loci. Behav Genet. 1996 Sep;26(5):519-25. doi: 10.1007/BF02359757.
- Background: PubMed 8571964Meyer JM, Han J, Singh R, Moxley G. Sex influences on the penetrance of HLA shared-epitope genotypes for rheumatoid arthritis. Am J Hum Genet. 1996 Feb;58(2):371-83.
- Background: PubMed 7945154Neale MC, Eaves LJ, Kendler KS. The power of the classical twin study to resolve variation in threshold traits. Behav Genet. 1994 May;24(3):239-58. doi: 10.1007/BF01067191.
- Background: PubMed 8024529Neale MC, Walters EE, Eaves LJ, Maes HH, Kendler KS. Multivariate genetic analysis of twin-family data on fears: Mx models. Behav Genet. 1994 Mar;24(2):119-39. doi: 10.1007/BF01067816.
- Background: PubMed 8150657Eaves LJ. Effect of genetic architecture on the power of human linkage studies to resolve the contribution of quantitative trait loci. Heredity (Edinb). 1994 Feb;72 ( Pt 2):175-92. doi: 10.1038/hdy.1994.25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
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 2 Mar 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 NCT00005355, which also lists 8 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 2 Mar 2016.