Cardiovascular DiseasesNCT00005512
Genetic Epidemiology--Development of Cardiovascular Risk
An observational study of Cardiovascular Diseases and Hypertension, run by Virginia Commonwealth University.
Trial summary
To determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1998to Jul 2002
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
No eligibility criteria
About this study
To determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults.
Read the detailed description
BACKGROUND:
Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD) and those with obesity have a greater risk of hypertension. In children and adolescents, high body mass index correlates with elevated blood pressure. Genetic factors make a significant contribution to the variation of obesity and hypertension.
DESIGN NARRATIVE:
Anthropometric, cardiovascular, physiologic and physical fitness data were used to investigate a series of critical issues about the etiology, heterogeneity, comorbidity and developmental trajectories of CVD risk factors, including obesity, hypertension and cardiovascular health. Using the two datasets, the main questions of the study were addressed. How do genes and environment act and interact to create covariation between obesity and hypertension, and were the genetic and environmental factors the same at all ages (from childhood to late adolescence and adulthood) in both sexes? Areas of research included the following: causes of individual differences in anthropometric and cardiovascular characteristics, their covariation and developmental change or continuity in adolescence, parent-offspring transmission, prediction of cardiovascular risk, and sex, race and population differences in genetic and environmental contributions on cardiovascular risk factors.
- Conditions
- Cardiovascular Diseases, Hypertension, Obesity, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Obesity, 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 startAug 1998
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Virginia Commonwealth UniversityThe 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
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Hermine Maes, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005512
- Sponsor's protocol ID
- 5030
- Other IDs
- R01HL060688
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 1 Mar 2016
- Results posted
- No
Publications
Beunen G, Thomis M, Maes HH, Loos R, Malina RM, Claessens AL, Vlietinck R. Genetic variance of adolescent growth in stature. Ann Hum Biol. 2000 Mar-Apr;27(2):173-86. doi: 10.1080/030144600282280.
PubMed 10768422Sicherer SH, Furlong TJ, Maes HH, Desnick RJ, Sampson HA, Gelb BD. Genetics of peanut allergy: a twin study. J Allergy Clin Immunol. 2000 Jul;106(1 Pt 1):53-6. doi: 10.1067/mai.2000.108105.
PubMed 10887305
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology--Development of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00005512
- Acronym / sponsor ID
- 5030
- Conditions
- Cardiovascular Diseases, Hypertension, Obesity, 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
- Aug 1998
- Study completion
- Jul 2002
- 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 determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults.
Detailed description
BACKGROUND:
Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD) and those with obesity have a greater risk of hypertension. In children and adolescents, high body mass index correlates with elevated blood pressure. Genetic factors make a significant contribution to the variation of obesity and hypertension.
DESIGN NARRATIVE:
Anthropometric, cardiovascular, physiologic and physical fitness data were used to investigate a series of critical issues about the etiology, heterogeneity, comorbidity and developmental trajectories of CVD risk factors, including obesity, hypertension and cardiovascular health. Using the two datasets, the main questions of the study were addressed. How do genes and environment act and interact to create covariation between obesity and hypertension, and were the genetic and environmental factors the same at all ages (from childhood to late adolescence and adulthood) in both sexes? Areas of research included the following: causes of individual differences in anthropometric and cardiovascular characteristics, their covariation and developmental change or continuity in adolescence, parent-offspring transmission, prediction of cardiovascular risk, and sex, race and population differences in genetic and environmental contributions on cardiovascular risk factors.
Study design
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 1 Mar 2016.
- Background: PubMed 10768422Beunen G, Thomis M, Maes HH, Loos R, Malina RM, Claessens AL, Vlietinck R. Genetic variance of adolescent growth in stature. Ann Hum Biol. 2000 Mar-Apr;27(2):173-86. doi: 10.1080/030144600282280.
- Background: PubMed 10887305Sicherer SH, Furlong TJ, Maes HH, Desnick RJ, Sampson HA, Gelb BD. Genetics of peanut allergy: a twin study. J Allergy Clin Immunol. 2000 Jul;106(1 Pt 1):53-6. doi: 10.1067/mai.2000.108105.
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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.
Hermine Maes
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, 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 1 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 NCT00005512, which also lists 2 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 1 Mar 2016.