Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Arthritis Foundation
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

• Female

• Member of the Michigan Lupus Cohort

• Meet the American College of Rheumatology (ACR) criteria for SLE

• Premenopausal

Exclusion Criteria:

• Smoker

• Diabetic

• Prednisone dose > 10 mg