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

University of Michigan13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Brachial artery reactivity, by flow mediated dilatation

Secondary Outcomes

Changes in biomarkers of SLE

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

Data from ClinicalTrials.gov

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