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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00189124
First received: September 13, 2005
Last updated: February 22, 2006
Last verified: September 2005
  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
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

Estimated Enrollment: 20
Study Start Date: June 2001
Estimated Study Completion Date: October 2006
  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

Contacts
Contact: Wendy Marder, MD (734) 936-1166 wmarder@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Wendy Marder, MD    734-936-1166    wmarder@umich.edu   
Principal Investigator: Wendy Marder, MD         
Sponsors and Collaborators
University of Michigan
Arthritis Foundation
Investigators
Principal Investigator: Wendy Marder, MD University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189124     History of Changes
Other Study ID Numbers: 2001-0822, GCRC# 1883
Study First Received: September 13, 2005
Last Updated: February 22, 2006
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
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014