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

This study has been completed.
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Wendy Marder, University of Michigan
ClinicalTrials.gov Identifier:
NCT00189124
First received: September 13, 2005
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Dehydroepiandrosterone (DHEA)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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

Enrollment: 13
Study Start Date: September 2003
Study Completion Date: July 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189124

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Arthritis Foundation
Investigators
Principal Investigator: Wendy Marder, MD University of Michigan
  More Information

Responsible Party: Wendy Marder, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00189124     History of Changes
Other Study ID Numbers: 2001-0822 
Study First Received: September 13, 2005
Last Updated: May 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Systemic Lupus Erythematosus
Dehydroepiandrosterone (DHEA)
DHEA
SLE
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016