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临床试验/NCT04066647
NCT04066647终止1 期

Detection of miRNAs in HPA Axis Function in Healthy Subjects

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年5月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
7
试验地点
1
主要终点
Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection

研究概览

简要总结

The proposed study will test dexamethasone effect on miRNA profile in healthy humans. As our data indicate that miRNA levels change over time, the investigators will study the time course of miRNA response to 1 mg IV dexamethasone within 60 minutes after injection. Dexamethasone is used routinely in human subjects for the treatment of inflammatory conditions and as a diagnostic tool in the evaluation of excess cortisol secretion (Cushing's syndrome). For the latter, 1 mg dexamethasone is given orally at midnight. Oral formula absorption in the gut can range from 20 to 60 minutes due to the presence of food and other factors. IV administration will bypass this variability and ensure an accurate and reproducible time-course study. The investigators will compare miRNA expression before and after dexamethasone treatment. The investigators will follow miRNA expression dynamics over a 1-hour time course to identify peak expression levels and to correlate miRNA expression with circulating dexamethasone levels. Dexamethasone and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection. Dexamethasone level is taken to verify treatment and to correlate it with miRNA expression.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age ≥ 18

排除标准

  • Pregnancy
  • Presence of a disease that affects HPA axis function
  • Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints
  • History of adverse event related to use of glucocorticoids

研究组 & 干预措施

Dexamthesone

Experimental

Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.

干预措施: Dexamethasone 4mg (Drug)

结局指标

主要结局

Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection

时间窗: Baseline and 60 minutes

The change of miRNA levels in blood between time of injection (baseline) and 60 minutes after injection. Expressed as miRx ratio: miR expression level normalized to miR7-2-1 expression level and divided by miRx expression at baseline (T0).

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

Anat Ben-Shlomo, MD

Staff Physician

Cedars-Sinai Medical Center

研究点 (1)

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