Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- improvement of endothelial function
研究概览
简要总结
The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial function in premenopausal women with SLE (systemic lupus erythematosus). Patients with hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast feeding women. This is a randomized, double blind, placebo controlled study.
详细描述
SLE (systemic lupus erythematosus) is characterized by accelerated atherosclerosis. The risk of suffering an acute myocardial infarction among premenopausal women with SLE is 50 times higher than control women of the same age. Insulin resistance and hyperinsulinemia are frequent in SLE. Lipid metabolism in SLE, as in other insulin resistant states, is characterized by high triglycerides, low HDL-cholesterol, normal LDL cholesterol (or slightly increased) and an increase in LDL's susceptibility to oxidation.
All these alterations can produce endothelial dysfunction which is present in SLE patients. Pioglitazone is a PPAR (peroxisome proliferator activated receptor) gamma agonist that can potentially improve insulin resistance, with a positive effect on the lipid profile (lowering of triglycerides, and a discrete increase in HDL-C) and improve endothelial function.
Patients will be randomized to receive either placebo or pioglitazone 30 mg/day during a period of 12 weeks. Endothelial function will be assessed by Positron Emission Tomography (PET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible participants were premenopausal women with SLE
- •Older than 18 years
- •Attending the outpatient Rheumatology Clinic at three Mexico City community tertiary care hospitals
排除标准
- •menopause
- •thyroid dysfunction
- •neurological
- •renal or liver disease
- •personal history of high blood pressure
- •CHD (coronary heart disease)
- •cerebrovascular events
- •chronic or acute infections
- •malignancy
- •nor history of chronic drugs or alcohol abuse
- •pregnancy or breast-feeding
- •intake of hormones or lipid-regulating drugs
研究组 & 干预措施
sugar pill
tablet similar to comparator
干预措施: placebo (Drug)
pioglitazone
30 mg tablets QD (taken once daily)
干预措施: pioglitazone (Drug)
结局指标
主要结局
improvement of endothelial function
时间窗: 12 weeks
Basal and final (12 weeks) endothelial function parameters measured by PET scan
次要结局
- change in HDL particle physicochemical characteristics(12 weeks)
研究者
Nacu Caracas Portilla
Juan Gabriel Juarez Rojas PhD
National Heart Institute, Mexico