Cardiovascular DiseasesNCT00037440
Genetic Epidemiology of Change in CVD Risk Factors
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
Trial summary
To extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime. Read more about this study
- Who is it for?
- Ages 8 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Polymorphisms measured
- How many people
- 1,735 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Aug 2005
- 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 8 to 38 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community study of schoolchildren in Bogalusa, Louisiana, with follow-up into young adulthood. Both whites and African Americans recruited.
Schoolchildren from Bogalusa, Louisiana. All children in Bogalusa public schools were eligible.
About this study
Official title: Genetic Epidemiology of Change in CVD Risk Factors (HL70568-1)
To extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime.
Read the detailed description
BACKGROUND:
While the onset of symptomatic cardiovascular disease (CVD) typically occurs in middle age or later, the development of the underlying pathology is clearly a long-term process, and early-state lesions having been identified at autopsy even in children. Understanding the course of CVD risk development from childhood into middle age will clearly be valuable both in understanding the pathology of CVD and in targeting preventive measures most effectively. Furthermore, while genetic factors are agreed to play a significant role in the development of CVD, most genes contributing to interindividual variation in CVD risk will have relatively small effects on risk for any given individual, even though their aggregate effects contribute significantly to CVD risk in the overall population. Relatively little is known about the effects of genetic variants on the course of CVD risk factor development in individuals over time. The Bogalusa Heart Study (BHS), which began in 1973 as a study of CVD risk factors in children but evolved to cover the development of CVD risk factors from childhood into early middle age, offers an unparalleled resource for investigating the genetic factors influencing within-individual changes over time in quantitative factors, such as serum lipids and blood pressure, related to CVD risk.
DESIGN NARRATIVE:
Approximately 1500 individuals who were examined in the BHS on at least three separate occasions over a period of up to 20 years, and who consented to participate in studies of genetic factors influencing CVD risk, will have genotypes measured at selected loci either known or strongly suspected to affect interindividual variation in CVD risk. Longitudinal multilevel regression will be used to measure the effects of variation at these loci on quantitative CVD risk factor profiles within individuals and to determine whether some gene effects on CVD risk variation are age-dependent.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Polymorphisms measured
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymorphisms measuredGenetic
| Study group | Role | What they receive |
|---|---|---|
| BHS Whites | Whites from Bogalusa, Louisiana; initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only. Receives: Genetic: Polymorphisms measured | |
| BHS African Americans | African Americans from Bogalusa, Louisiana, initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only. Receives: Genetic: Polymorphisms measured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipid levels
Measured: Change from 8 - 18 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startSep 2001
- 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 (1)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 The University of Texas Health Science Center, HoustonThe 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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,735 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michael Hallman, The University of Texas Health Science Center, Houston
- Investigators
- David Hallman, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037440
- Sponsor's protocol ID
- 1171
- Other IDs
- R01HL070568
- Status last verified
- Dec 2014
- First submitted
- 16 May 2002
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hallman DM, Srinivasan SR, Chen W, Boerwinkle E, Berenson GS. The beta(2)-adrenergic receptor Arg16-gly polymorphism and interactions involving beta(2)- and beta(3)-adrenergic receptor polymorphisms are associated with variations in longitudinal serum lipid profiles: the Bogalusa Heart Study. Metabolism. 2004 Sep;53(9):1184-91. doi: 10.1016/j.metabol.2004.03.019.
PubMed 15334382
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Change in CVD Risk Factors (HL70568-1)
- ClinicalTrials.gov ID
- NCT00037440
- Acronym / sponsor ID
- 1171
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,735 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2001
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 17 May 2002 (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 extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime.
Detailed description
BACKGROUND:
While the onset of symptomatic cardiovascular disease (CVD) typically occurs in middle age or later, the development of the underlying pathology is clearly a long-term process, and early-state lesions having been identified at autopsy even in children. Understanding the course of CVD risk development from childhood into middle age will clearly be valuable both in understanding the pathology of CVD and in targeting preventive measures most effectively. Furthermore, while genetic factors are agreed to play a significant role in the development of CVD, most genes contributing to interindividual variation in CVD risk will have relatively small effects on risk for any given individual, even though their aggregate effects contribute significantly to CVD risk in the overall population. Relatively little is known about the effects of genetic variants on the course of CVD risk factor development in individuals over time. The Bogalusa Heart Study (BHS), which began in 1973 as a study of CVD risk factors in children but evolved to cover the development of CVD risk factors from childhood into early middle age, offers an unparalleled resource for investigating the genetic factors influencing within-individual changes over time in quantitative factors, such as serum lipids and blood pressure, related to CVD risk.
DESIGN NARRATIVE:
Approximately 1500 individuals who were examined in the BHS on at least three separate occasions over a period of up to 20 years, and who consented to participate in studies of genetic factors influencing CVD risk, will have genotypes measured at selected loci either known or strongly suspected to affect interindividual variation in CVD risk. Longitudinal multilevel regression will be used to measure the effects of variation at these loci on quantitative CVD risk factor profiles within individuals and to determine whether some gene effects on CVD risk variation are age-dependent.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHS Whites | – | Genetic: Polymorphisms measuredWhites from Bogalusa, Louisiana; initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only. |
| BHS African Americans | – | Genetic: Polymorphisms measuredAfrican Americans from Bogalusa, Louisiana, initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only. |
Who may qualify
- Ages
- 8 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community study of schoolchildren in Bogalusa, Louisiana, with follow-up into young adulthood. Both whites and African Americans recruited.
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 |
|---|---|---|
| Polymorphisms measured | Genetic | BHS African Americans, BHS Whites |
Primary outcome
Plasma lipid levels
Time frame: Change from 8 - 18 years of age
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 3 Dec 2014.
- Background: PubMed 15334382Hallman DM, Srinivasan SR, Chen W, Boerwinkle E, Berenson GS. The beta(2)-adrenergic receptor Arg16-gly polymorphism and interactions involving beta(2)- and beta(3)-adrenergic receptor polymorphisms are associated with variations in longitudinal serum lipid profiles: the Bogalusa Heart Study. Metabolism. 2004 Sep;53(9):1184-91. doi: 10.1016/j.metabol.2004.03.019.
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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.
David Hallman principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
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 3 Dec 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.
What does the primary outcome measure?
Plasma lipid levels (time frame: Change from 8 - 18 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00037440, which also lists 1 linked publication.
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 3 Dec 2014.