Β-受体阻滞剂对炎症和神经应激反应的影响
2025年10月27日 更新者：University of North Carolina, Chapel Hill
这项研究的目的是绘制心理压力引起的炎症变化背后的神经和分子机制，这可能揭示降低心血管疾病风险的干预新目标。
研究概览
详细说明
拟议的工作将利用非选择性 β 肾上腺素受体阻滞剂普萘洛尔进行机械临床试验，以检查 β 肾上腺素信号在塑造神经和炎症应激反应中的作用。
研究人员将重点关注β-肾上腺素能信号传导，因为开创性的临床前工作表明，这种分子途径是压力相关炎症增加的重要驱动因素，而最初的人类神经影像学工作表明，β-阻断会导致神经对负性反应的变化。刺激。
在这里，研究人员将把这两个以前不同的工作结合在一起，以确定通过实验阻断一个关键的压力信号通路如何影响神经活动和对压力的炎症反应。
在此过程中，研究人员将通过绘制机制（即β-肾上腺素信号传导）、提供方法改进（即超越相关性而使用药理学操作提供因果证据）和确定干预目标（即神经认知）来推进知识的发展。响应β-封锁而改变活动/连接的系统）。
总之，本文提出的工作意义重大，因为它将解决一种关键危险因素（心理压力）可能最终通过炎症导致心血管疾病的机制。
拟议的研究还通过使用神经影像学来识别神经认知途径，并使用药理学来提供因果实验证据，使我们超越相关性，从而对过去的工作提供了显着的方法学改进。
最后，该项目意义重大，因为它可以为未来干预措施的新目标提供见解。
研究类型
介入性
注册 (估计的)
120
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Keely A Muscatell, PhD
- 电话号码：9164957661
- 邮箱：kmuscatell@unc.edu
研究联系人备份
- 姓名：Jonathan Bunting, BS
- 电话号码：9164957661
- 邮箱：jonb@unc.edu
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- 招聘中
- Social Neuroscience and Health Laboratory
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接触：
- Keely A Muscatell, PhD
- 电话号码：916-495-7661
- 邮箱：kmuscatell@unc.edu
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副研究员：
- Jessica R Cohen, PhD
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副研究员：
- Kristen A Lindquist, PhD
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副研究员：
- Zev Nakamura, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
纳入标准：
- 年龄18-30岁
- 右手
- 英语阅读、写作和口语流利，至少达到 10 年级水平
- 体重指数 (BMI) 小于或等于 35 kg/m^2
排除标准：
作为筛选评估，在第一阶段重新评估：
- 体内不可拆卸的金属装置/植入物/物体
- 严重幽闭恐惧症（通过自我报告评估）
- 目前怀孕了
- 左撇子
- 体重指数 (BMI) 大于 35 kg/m^2
- 有晕厥史或任何心脏病史
- 有低静息心率 (< 60 BPM) 和/或低血压（收缩压 < 80mmHg）病史或目前存在
- 自我报告的身体疾病：糖尿病、心血管疾病、高血压、炎症性肠病、类风湿性关节炎、哮喘、自身免疫性疾病、克罗恩病、溃疡性结肠炎、狼疮
- 任何自我报告的诊断出的精神疾病
- 目前使用处方药
- 当前或最近经常使用尼古丁/烟草（香烟、电子烟、电子烟、咀嚼烟草、尼古丁口香糖）
- 目前定期（每天或几乎每天）使用消遣性药物=每周 4 次或以上
在第一节中提出指示，在第二节中重新评估：
- 过去两周内接种过任何疫苗
- 第二节课前一天晚上严重睡眠障碍（睡眠不足 3-4 小时）
- 第二节当天进行剧烈的体力活动
- 第二节当天出现急性疾病或过敏症状
- 第二节当天使用非处方药
- 第二节课后 48 小时内使用消遣性药物
- 第二节当天的饮酒情况
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：普萘洛尔
普萘洛尔片剂，40mg，一次性，口服
|
片剂经过封装，视觉上看起来与安慰剂相同。
其他名称：
|
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安慰剂比较：安慰剂
胶囊安慰剂片剂
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封装的糖丸在视觉上看起来与实验条件相同。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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促炎细胞因子白细胞介素 6 水平因社会压力而发生变化
大体时间：药物后基线至 90 分钟应激后任务 (T-90)
|
将分析血浆中促炎细胞因子白细胞介素 6 (IL-6) 的水平，从基线、给药后的基线、压力任务 (T-90) 后 90 分钟的样本（以 pg/mL 为单位测量）进行分析。
该时间线是根据荟萃分析工作确定的，显示炎症细胞因子 IL-6 的变化在应激后 90 分钟时最大。
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药物后基线至 90 分钟应激后任务 (T-90)
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炎症基因表达水平因社会压力而变化
大体时间：药物后基线至 30 分钟应激后任务 (T-30)
|
全血样本将收集在 PaxGene 管中，并分析炎症基因表达相对于基线、给药后基线以及应激任务后 30 分钟 (T-30) 的变化，以每百万个基因转录本计数进行测量。
该时间线基于首席研究员的工作，该工作表明在应激后 30 分钟观察到促炎基因表达的变化。
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药物后基线至 30 分钟应激后任务 (T-30)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Keely Muscatell, PhD、University of North Carolina, Chapel Hill
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年5月1日
初级完成 (估计的)
2026年5月1日
研究完成 (估计的)
2026年5月1日
研究注册日期
首次提交
2024年1月31日
首先提交符合 QC 标准的
2024年2月8日
首次发布 (实际的)
2024年2月16日
研究记录更新
最后更新发布 (估计的)
2025年10月29日
上次提交的符合 QC 标准的更新
2025年10月27日
最后验证
2025年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.