search
Back to results

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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dehydroepiandrosterone (DHEA)
Sponsored by
University of Michigan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Outcomes

Primary Outcome Measures

Brachial artery reactivity, by flow mediated dilatation

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
May 17, 2016
Sponsor
University of Michigan
Collaborators
Arthritis Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00189124
Brief Title
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention
Official Title
Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Arthritis Foundation

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: changes in brachial artery flow-mediated dilatation (FMD) and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone (DHEA)
Primary Outcome Measure Information:
Title
Brachial artery reactivity, by flow mediated dilatation
Secondary Outcome Measure Information:
Title
Changes in biomarkers of SLE
Title
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Marder, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs