Β-受体阻滞剂对炎症和神经应激反应的影响
2026年11月2日 更新者：University of North Carolina, Chapel Hill
The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease.
研究概览
详细说明
The proposed work will conduct a mechanistic clinical trial utilizing the non-selective beta-adrenergic receptor blocker propranolol to examine the role of beta-adrenergic signaling in shaping neural and inflammatory responses to stress. The investigators will focus on beta-adrenergic signaling given seminal pre-clinical work showing that this molecular pathway is an important driver of stress-related increases in inflammation, and initial human neuroimaging work showing that beta-blockade leads to changes in neural responses to negative stimuli. Here, the investigators will bring these two previously disparate lines of work together to determine how experimentally blocking one critical stress-signaling pathway shapes neural activity and inflammatory responses to stress. In doing so, the investigators will be advancing knowledge by mapping mechanisms (i.e., beta-adrenergic signaling), offering methodological improvements (i.e., moving beyond correlation to using pharmacological manipulations to provide causal evidence), and identifying intervention targets (i.e., the neurocognitive systems that shift activity/connectivity in response to beta-blockade). In sum, the work proposed herein is significant because it will address the mechanisms by which one critical risk factor, psychological stress, may ultimately lead to cardiovascular disease via inflammation. The proposed study also offers significant methodological improvements over past work by using neuroimaging to identify neurocognitive pathways, and pharmacology to provide causal experimental evidence to move us beyond correlation. Finally, this project is significant because it could provide insight into novel targets for future interventions.
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
-
副研究员：
- Jessica R Cohen, PhD
-
副研究员：
- Kristen A Lindquist, PhD
-
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
18年 至 30年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ages 18-30 years
- Right-handed
- Fluent in English reading, writing, and speaking at least at a 10th grade level
- Body mass index (BMI) less than or equal to 35 kg/m^2
Exclusion Criteria:
Assessed as screening, reassessed at Session I:
- Non-removeable metal devices/implants/objects in the body
- Severe claustrophobia (assessed by self-report)
- Currently pregnant
- Left-handed
- Body mass index (BMI) greater than 35 kg/m^2
- History of fainting spells or any heart condition
- History of or present low resting heart rate (< 60 BPM) and/or low blood pressure (systolic blood pressure < 80mmHg)
- Self-reported physical illnesses: diabetes, cardiovascular diseases, high blood pressure, inflammatory bowel diseases, rheumatoid arthritis, asthma, autoimmune disease, Crohn's disease, ulcerative colitis, lupus
- Any self-reported diagnosed mental illness
- Current use of prescription medications (except hormonal contraceptives)
- Current or recent regular nicotine/tobacco use (cigarettes, e-cigarettes, vape, chewing tobacco, nicotine gum)
- Current regular (daily or almost daily) recreational drug use = 4 or more times per week
Instructed against during Session I, reassessed at Session II:
- Received any vaccine within the past two weeks
- Severe sleep disturbance (3-4 hours of sleep loss) the night before Session II
- Vigorous physical activity on the day of Session II
- Acute illness or allergy symptoms on the day of Session II
- Usage of over-the-counter medications on the day of Session II
- Usage of recreational drugs within 48 hours of Session II
- Usage of alcohol on the day of Session II
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：Propranolol
Propranolol tablet, 40mg, one-time, orally |
Tablet encapsulated to visually look identical to the placebo.
其他名称：
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安慰剂比较：Placebo
Encapsulated placebo tablet |
Encapsulated sugar pill to visually look identical to the experimental condition.
其他名称：
|
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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Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress
大体时间：Post-drug baseline to 90-minutes post-stress task (T-90)
|
Blood plasma will be analyzed for levels of pro-inflammatory cytokine interleukin-6 (IL-6), from baseline, a baseline after drug administration, a sample 90-minutes after the stress task (T-90) measured in pg/mL. The timeline was determined on meta-analytic work showing changes in the inflammatory cytokine IL-6 are largest at 90 minutes post-stress. |
Post-drug baseline to 90-minutes post-stress task (T-90)
|
|
Change in levels of inflammatory gene expression in response to social stress
大体时间：Post-drug baseline to 30-minutes post-stress task (T-30)
|
Whole blood samples will be collected in PaxGene tubes and analyzed for changes in inflammatory gene expression from baseline, a baseline after drug administration, and 30-minutes after the stress task (T-30), measured in gene transcript counts per million. The timeline is based on the Principal Investigator's work showing that changes in pro-inflammatory gene expression are observed 30-minutes post-stress. |
Post-drug baseline to 30-minutes post-stress task (T-30)
|
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
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2027年2月1日
研究完成 (估计的)
2027年2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 (实际的)
2026年11月5日
上次提交的符合 QC 标准的更新
2026年11月2日
最后验证
2026年11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.