Cardiovascular DiseasesNCT00005470
Divergence of Blood Pressure By Race in Adolescent Girls
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS) for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood volume, whole blood viscosity, and left… 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, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1996to Aug 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS) for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood volume, whole blood viscosity, and left ventricular contractility.
Read the detailed description
BACKGROUND:
African-American women have a substantially higher prevalence of hypertension and suffer greater morbidity and mortality due to blood pressure elevation than white-American women. Much of this ethnic difference in blood pressure is due to increased obesity in African-American women. In contrast, young African-American and white-American girls have similar levels of obesity and blood pressure. The hemodynamic changes that occur with developing obesity and result in this ethnic difference in blood pressure have not been well characterized. Cross-sectional studies of adolescents have shown that despite similar blood pressure levels, African-Americans have higher total peripheral resistance while whites have higher cardiac output. Cross-sectional studies of adults show that obesity is associated with elevation of cardiac output. If such an obesity-related increase in cardiac output is superimposed on the underlying elevation of total peripheral resistance in African-American girls, these hemodynamic factors could be responsible for the developing ethnic divergence in blood pressure seen in late adolescence as African-American girls develop an increasing prevalence and severity of obesity.
This investigation will provide important new knowledge regarding the longitudinal changes and interrelationships among the potential hemodynamic factors which define the association between developing obesity and blood pressure elevation. In the clinical setting where obesity is very difficult to prevent or treat, it is important to understand the mechanisms by which obesity results in elevated blood pressure. The results of this cohort study will provide the basis for rational and specific clinical strategies to interrupt the pathophysiologic process by which obesity leads to hypertension and places African-American women at particularly increased risk for cardiovascular disease morbidity and mortality.
The NGHS was initiated by the NHLBI in 1985 as a contract-supported program to determine if the Black-white differences in the development of obesity in 2,379 pubescent females were due to differences in psychosocial, socioeconomic and other environmental factors. The study also sought to determine whether differences in the development of obesity led to Black-white differences in other coronary heart disease risk factors, such as blood pressure and serum lipids. The study has been renewed twice, the last time as an investigator-initiated study. See the National Growth and Health Study for the complete write-up.
DESIGN NARRATIVE:
The ancillary study is a prospective cohort study of 355 African-American and 315 white-American females from the NHLBl Growth and Health Study as these women progress from age 18-19 years to age 21-22 years. The study includes yearly measurement of anthropometrics, blood pressure, and echocardiographic determination of cardiac output and total peripheral resistance. In addition, factors which may relate to changes in cardiac output and total peripheral resistance, such as circulating blood volume (left ventricular end-diastolic volume), heart rate, left ventricular contractility, whole blood viscosity, and left ventricular mass and geometry are measured.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
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 1996
- Study completionAug 2002
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 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
- Stephen Daniels, Children's Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005470
- Sponsor's protocol ID
- 4952
- Other IDs
- R01HL052911
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Kimm SY, Glynn NW, Aston CE, Poehlman ET, Daniels SR. Effects of race, cigarette smoking, and use of contraceptive medications on resting energy expenditure in young women. Am J Epidemiol. 2001 Oct 15;154(8):718-24. doi: 10.1093/aje/154.8.718.
PubMed 11590084
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divergence of Blood Pressure By Race in Adolescent Girls
- ClinicalTrials.gov ID
- NCT00005470
- Acronym / sponsor ID
- 4952
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Aug 2002 (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 continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS) for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood volume, whole blood viscosity, and left ventricular contractility.
Detailed description
BACKGROUND:
African-American women have a substantially higher prevalence of hypertension and suffer greater morbidity and mortality due to blood pressure elevation than white-American women. Much of this ethnic difference in blood pressure is due to increased obesity in African-American women. In contrast, young African-American and white-American girls have similar levels of obesity and blood pressure. The hemodynamic changes that occur with developing obesity and result in this ethnic difference in blood pressure have not been well characterized. Cross-sectional studies of adolescents have shown that despite similar blood pressure levels, African-Americans have higher total peripheral resistance while whites have higher cardiac output. Cross-sectional studies of adults show that obesity is associated with elevation of cardiac output. If such an obesity-related increase in cardiac output is superimposed on the underlying elevation of total peripheral resistance in African-American girls, these hemodynamic factors could be responsible for the developing ethnic divergence in blood pressure seen in late adolescence as African-American girls develop an increasing prevalence and severity of obesity.
This investigation will provide important new knowledge regarding the longitudinal changes and interrelationships among the potential hemodynamic factors which define the association between developing obesity and blood pressure elevation. In the clinical setting where obesity is very difficult to prevent or treat, it is important to understand the mechanisms by which obesity results in elevated blood pressure. The results of this cohort study will provide the basis for rational and specific clinical strategies to interrupt the pathophysiologic process by which obesity leads to hypertension and places African-American women at particularly increased risk for cardiovascular disease morbidity and mortality.
The NGHS was initiated by the NHLBI in 1985 as a contract-supported program to determine if the Black-white differences in the development of obesity in 2,379 pubescent females were due to differences in psychosocial, socioeconomic and other environmental factors. The study also sought to determine whether differences in the development of obesity led to Black-white differences in other coronary heart disease risk factors, such as blood pressure and serum lipids. The study has been renewed twice, the last time as an investigator-initiated study. See the National Growth and Health Study for the complete write-up.
DESIGN NARRATIVE:
The ancillary study is a prospective cohort study of 355 African-American and 315 white-American females from the NHLBl Growth and Health Study as these women progress from age 18-19 years to age 21-22 years. The study includes yearly measurement of anthropometrics, blood pressure, and echocardiographic determination of cardiac output and total peripheral resistance. In addition, factors which may relate to changes in cardiac output and total peripheral resistance, such as circulating blood volume (left ventricular end-diastolic volume), heart rate, left ventricular contractility, whole blood viscosity, and left ventricular mass and geometry are measured.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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 18 Feb 2016.
- Background: PubMed 11590084Kimm SY, Glynn NW, Aston CE, Poehlman ET, Daniels SR. Effects of race, cigarette smoking, and use of contraceptive medications on resting energy expenditure in young women. Am J Epidemiol. 2001 Oct 15;154(8):718-24. doi: 10.1093/aje/154.8.718.
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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.
Stephen Daniels
Children's Hospital & Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, 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 18 Feb 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 NCT00005470, 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 18 Feb 2016.