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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00189124
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2005-12
• Study Completion: 2006-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brachial artery reactivity, by flow mediated dilatation

Secondary Outcome Measures

Name	Time	Method
Changes in biomarkers of SLE
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States