Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005160
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2000-05-25
Brief Title:
Epidemiology of Cardiovascular Risk Factors in Women Healthy Women Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Epidemiology of Cardiovascular Risk Factors in Women Healthy Women Study
Status:
COMPLETED
Status Verified Date:
2016-01
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 determine cardiovascular risk factors and the change in risk factors during and following the menopause
Detailed Description:
BACKGROUND
In 1983 when the Healthy Women Study began there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause The Healthy Women Study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause The study also included detailed behavioral and biological measures as well as important environmental factors related to the determinants of these risk factors
DESIGN NARRATIVE
A cross-sectional study was conducted to determine the relationship between risk factors behavioral psychosocial and other environmental determinants A five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods Longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior hormones habits and risk factors
The women had home interviews baseline examinations follow-up of menstrual cycles and a six-month self-administered questionnaire Risk factors studied included behavioral factors glucose and insulin obesity exercise cigarette smoking nutrition lipoproteins blood pressure and hormones Surgical menopause and the use of exogenous hormones were also studied Although not part of the original protocol measurements of fat distribution coagulation factors apoproteins sodium-lithium counter-transport and sodium-hydrogen exchange in platelets were added
The study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors behavioralpsychological attributes and to determine the relationship between risk factors and their changes and atherosclerotic plaque and wall thickness Studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis A determination is made of the association of lifestyle to amount and distribution of body fat measured by DEXA and CT of the abdomen
The study has been renewed several times and ends in November of 2007
In 1983 when the Healthy Women Study began there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause The Healthy Women Study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause The study also included detailed behavioral and biological measures as well as important environmental factors related to the determinants of these risk factors
DESIGN NARRATIVE
A cross-sectional study was conducted to determine the relationship between risk factors behavioral psychosocial and other environmental determinants A five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods Longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior hormones habits and risk factors
The women had home interviews baseline examinations follow-up of menstrual cycles and a six-month self-administered questionnaire Risk factors studied included behavioral factors glucose and insulin obesity exercise cigarette smoking nutrition lipoproteins blood pressure and hormones Surgical menopause and the use of exogenous hormones were also studied Although not part of the original protocol measurements of fat distribution coagulation factors apoproteins sodium-lithium counter-transport and sodium-hydrogen exchange in platelets were added
The study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors behavioralpsychological attributes and to determine the relationship between risk factors and their changes and atherosclerotic plaque and wall thickness Studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis A determination is made of the association of lifestyle to amount and distribution of body fat measured by DEXA and CT of the abdomen
The study has been renewed several times and ends in November of 2007
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 |
|---|---|---|---|
| R01HL028266-26 | NIH | None | httpsreporternihgovquickSearchR01HL028266-26 |