베타 차단제가 스트레스에 대한 염증 및 신경 반응에 미치는 영향
2026년 11월 2일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
120
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Keely A Muscatell, PhD
- 전화번호: 9164957661
- 이메일: kmuscatell@unc.edu
연구 연락처 백업
- 이름: Jonathan Bunting, BS
- 전화번호: 9164957661
- 이메일: jonb@unc.edu
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- 모병
- Social Neuroscience and Health Laboratory
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연락하다:
- Keely A Muscatell, PhD
- 전화번호: 916-495-7661
- 이메일: kmuscatell@unc.edu
-
부수사관:
- Jessica R Cohen, PhD
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부수사관:
- Kristen A Lindquist, PhD
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부수사관:
- Zev Nakamura, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Propranolol
Propranolol tablet, 40mg, one-time, orally |
Tablet encapsulated to visually look identical to the placebo.
다른 이름들:
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위약 비교기: Placebo
Encapsulated placebo tablet |
Encapsulated sugar pill to visually look identical to the experimental condition.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress
기간: Post-drug baseline to 90-minutes post-stress task (T-90)
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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)
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Change in levels of inflammatory gene expression in response to social stress
기간: Post-drug baseline to 30-minutes post-stress task (T-30)
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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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Keely Muscatell, PhD, University of North Carolina, Chapel Hill
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2024년 5월 1일
기본 완료 (추정된)
기본 완료
2027년 2월 1일
연구 완료 (추정된)
연구 완료
2027년 2월 1일
연구 등록 날짜
최초 제출
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 23-2768
- 1R01HL157422-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
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아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .