Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361075
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2006-08-03
Brief Title:
Midlife Cholesterol Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Mentored Patient Oriented Research Career Development Award
Status:
COMPLETED
Status Verified Date:
2014-11
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 postmenopausal state is associated with an increase risk for heart disease Much of this increase in risk may be due to the loss of estrogen the main female hormone and the effect of this loss on lipids blood fats This loss of estrogen is often treated by estrogen replacement therapy Estrogen replacement therapy seems to have a beneficial effect on lipid levels The purpose of this research study is to understand 1 how menopause affects lipids and 2 how hormone replacement therapy effects the lipid metabolism of postmenopausal women
Detailed Description:
Women with the Metabolic Syndrome central obesity insulin resistance and dyslipidemia are at especially high risk for coronary heart disease CHD The prevalence of the Metabolic Syndrome increases with menopause and may partially explain the acceleration in CHD after menopause Menopause is associated with increased central adiposity insulin resistance dyslipidemia hypertriglyceridemia increased low density lipoprotein LDL reduced high density lipoprotein HDL and small dense LDL particles and increased thromboticinflammatory states but there are no studies investigating the mechanisms that mediate these changes The objectives of the proposed project are to investigate the emergence of the features of the Metabolic Syndrome in women followed prospectively through the menopause and determine if these features can be reversed with transdermal estrogen We hypothesize that the increase in central adiposity with menopause will be a major contributor to the increased prevalence of the Metabolic Syndrome with menopause This is the first prospective study to investigate the 1 effects of menopause and 2 estrogen replacement therapy ERT oral vs transdermal on features of the Metabolic Syndrome We will determine if the increase in central intraabdominalfat with menopause is associated with changes in lipids insulin resistance adipocytokines and fibrinolyticinflammatory markers We will then determine if these changes can be reversed with transdermal ERT as compared to oral ERT which has pharmacologic effects on the liver
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