Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus
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.
Interventions
Sponsors
Arthritis Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brachial artery reactivity, by flow mediated dilatation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in biomarkers of SLE | — |
| Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score | — |
Countries
United States
Outcome results
None listed