Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189124
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2005-09-13
Brief Title:
Dehydroepiandrosterone DHEA in Systemic Lupus Erythematosus SLE for Coronary Artery Disease CAD Prevention
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring
1 changes in brachial artery flow-mediated dilatation FMD and
2 changes in biomarkers of cardiovascular risk Patients will be enrolled in a randomized double-blinded crossover trial of DHEA or placebo for ten weeks then crossed over to the alternate treatment arm after a six-week washout period
HYPOTHESIS Dehydroepiandrosterone DHEA administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease
1 changes in brachial artery flow-mediated dilatation FMD and
2 changes in biomarkers of cardiovascular risk Patients will be enrolled in a randomized double-blinded crossover trial of DHEA or placebo for ten weeks then crossed over to the alternate treatment arm after a six-week washout period
HYPOTHESIS Dehydroepiandrosterone DHEA administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease
Detailed Description:
None
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