Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081692
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2004-04-19
Brief Title:
Longitudinal Cardiac Outcomes and Body Composition
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Longitudinal Cardiac Outcomes and Body Composition
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To relate cardiac structure and blood pressure BP elevation in adults to childhood BP and body size and composition
Detailed Description:
BACKGROUND
To describe growth events adequately long-term serial data with frequent measurements at appropriate ages are necessary The study uses the Fels Longitudinal Study In the Fels Longitudinal Study data collection begins at birth and all children are scheduled for measurements semiannually on their birthdays and half birthdays until the age of 18 years after which they are scheduled every 2 years The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood
DESIGN NARRATIVE
The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size body composition and blood pressure To address this goal 685 adult white active participants in the Fels Longitudinal Study 352 men and 333 women 20 to 70 years of age will be studied These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure The innovative longitudinal statistical analysis used will include covariates such as age gender birth year for secular trend adulthood lifestyle smoking alcohol consumption and physical activity adult body size and composition menopause and medical condition and medication use The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index BMI Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters
To describe growth events adequately long-term serial data with frequent measurements at appropriate ages are necessary The study uses the Fels Longitudinal Study In the Fels Longitudinal Study data collection begins at birth and all children are scheduled for measurements semiannually on their birthdays and half birthdays until the age of 18 years after which they are scheduled every 2 years The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood
DESIGN NARRATIVE
The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size body composition and blood pressure To address this goal 685 adult white active participants in the Fels Longitudinal Study 352 men and 333 women 20 to 70 years of age will be studied These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure The innovative longitudinal statistical analysis used will include covariates such as age gender birth year for secular trend adulthood lifestyle smoking alcohol consumption and physical activity adult body size and composition menopause and medical condition and medication use The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index BMI Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072838-05 | NIH | None | httpsreporternihgovquickSearchR01HL072838-05 |