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临床试验/NCT05331053
NCT05331053终止4 期

MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Penn State University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
6
试验地点
1
主要终点
Change in Nitric Oxide Dependent Vasodilation in the Skin

研究概览

简要总结

Endometriosis is a disorder that occurs in women. With endometriosis, tissue that should be found in the womb is found in sites outside of the womb. This disorder impairs the function of the cells that line the body's blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder have an increased risk for high blood pressure and high cholesterol. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease.

详细描述

Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, Low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. We hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is microRNA (miRNA) activation of LOX-1 receptor mechanisms.

Specific Aim 1. To test the hypothesis that LOX-1 receptor activation is increased leading to endothelial dysfunction in endometriosis.

Specific Aim 2. To test the hypothesis that decreased microRNAs (i.e. let7-a, let7-b, let7-g, MiR98, Mi590-p) are driving increased LOX-1 receptor expression and function in endometriosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician <5 years prior, and reported by the subject to the researchers)

排除标准

  • Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
  • Diabetes (HbA1C .6.5%)
  • BP>140/90
  • Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
  • Pregnancy
  • Breastfeeding
  • Taking illicit and/or recreational drugs
  • Abnormal liver function
  • Rash, skin disease, disorders of pigmentation, known skin allergies
  • Diagnosed or suspected metabolic or cardiovascular disease
  • Persistent unexplained elevations of serum transaminases
  • Known allergy to latex or investigative substances

研究组 & 干预措施

Atorvastatin

Experimental

Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days.

Atorvastatin acts as a systemic LOX inhibitor.

干预措施: Atorvastatin (Drug)

结局指标

主要结局

Change in Nitric Oxide Dependent Vasodilation in the Skin

时间窗: before and after intervention (7 days)

area under the curve of laser Doppler flux/mean arterial pressure \* log acetylcholine (mol/L)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lacy Alexander

Professor of Kinesiology, Physiology

Penn State University

研究点 (1)

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