Obesity Clinical Trial
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.
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.
;
N/A
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
| Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
| Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
| Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
| Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
| Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
| Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
| Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
| Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
| Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
| Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
| Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
| Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
| Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
| Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
| Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |