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

This study is currently recruiting participants.

Verified by University of Michigan, September 2005

First Received: September 13, 2005 Last Updated: February 22, 2006 History of Changes

Sponsors and Collaborators:	University of Michigan Arthritis Foundation
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00189124

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Dehydroepiandrosterone (DHEA)	Phase II Phase III

MedlinePlus related topics: Coronary Artery Disease Lupus

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?

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

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

Study ID Numbers:	2001-0822, GCRC# 1883
Study First Received:	September 13, 2005
Last Updated:	February 22, 2006
ClinicalTrials.gov Identifier:	NCT00189124 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Michigan:

Systemic Lupus Erythematosus
Dehydroepiandrosterone (DHEA)
DHEA
SLE
Lupus

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Autoimmune Diseases
Immunologic Factors
Myocardial Ischemia
Lupus
Adjuvants, Immunologic
Vascular Diseases

Dehydroepiandrosterone
Ischemia
Arteriosclerosis
Coronary Disease
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Adjuvants, Immunologic
Vascular Diseases

Dehydroepiandrosterone
Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009