NCT00189124已完成2 期
Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Brachial artery reactivity, by flow mediated dilatation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Member of the Michigan Lupus Cohort
- •Meet the American College of Rheumatology (ACR) criteria for SLE
- •Premenopausal
排除标准
- •Prednisone dose > 10 mg
结局指标
主要结局
Brachial artery reactivity, by flow mediated dilatation
次要结局
- Changes in biomarkers of SLE
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score
研究者
Wendy Marder
Associate Professor
University of Michigan
研究点 (2)
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