Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023543
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-09-07
Brief Title:
Reduction of Triglycerides in Women on Hormone Replacement Therapy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Reduction of Triglycerides in Women on HRT
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy HRT
Detailed Description:
BACKGROUND
Cardiovascular disease is a common cause of morbidity and mortality in older women Better methods of prevention via health promotion are needed Estrogen HRT may beneficially affect womens cardiovascular health based on evidence from observational studies but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users Understanding this untoward effect of HRT and how to prevent it is a significant aim
DESIGN NARRATIVE
This randomized trial of 500 women on HRT for at least two years aged 52-60 years and three or more years postmenopausal will test whether reduction in waist circumference triglycerides dense low density lipoprotein cholesterol LDLc number of LDL particles C-reactive protein and plasminogen activator inhibitor-I PAI-I by aggressive diet and exercise versus a health education control and will decrease progression or result in regression of measures of subclinical vascular disease The intervention is designed to reduce total fat intake to 17 percent of calories 1300 kilo calories and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels a 5 cm decrease in waist circumference and a 10 percent decrease in LDLc This will result in changes in subclinical measurements including carotid ultrasound electron beam computer tomography of the coronary artery and aorta pulse wave velocity endothelial function and tonometry of the radial artery Nuclear magnetic resonance spectroscopy of lipoproteins inflammatory markers and estrogen metabolites will also be evaluated
Cardiovascular disease is a common cause of morbidity and mortality in older women Better methods of prevention via health promotion are needed Estrogen HRT may beneficially affect womens cardiovascular health based on evidence from observational studies but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users Understanding this untoward effect of HRT and how to prevent it is a significant aim
DESIGN NARRATIVE
This randomized trial of 500 women on HRT for at least two years aged 52-60 years and three or more years postmenopausal will test whether reduction in waist circumference triglycerides dense low density lipoprotein cholesterol LDLc number of LDL particles C-reactive protein and plasminogen activator inhibitor-I PAI-I by aggressive diet and exercise versus a health education control and will decrease progression or result in regression of measures of subclinical vascular disease The intervention is designed to reduce total fat intake to 17 percent of calories 1300 kilo calories and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels a 5 cm decrease in waist circumference and a 10 percent decrease in LDLc This will result in changes in subclinical measurements including carotid ultrasound electron beam computer tomography of the coronary artery and aorta pulse wave velocity endothelial function and tonometry of the radial artery Nuclear magnetic resonance spectroscopy of lipoproteins inflammatory markers and estrogen metabolites will also be evaluated
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 |
|---|---|---|---|
| R01HL066468-06 | NIH | None | None |
| R01HL066468 | NIH | None | httpsreporternihgovquickSearchR01HL066468 |