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临床试验/NCT03637751
NCT03637751已完成不适用

Temporal Genomics Mechanisms Underlying Disease and Aging

Penn State University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Gene expression via RNAseq

研究概览

简要总结

Given the salient role of early-life adversity and the resulting biological embedding in disease risk, there is a critical need to understand the mechanisms operating at multiple levels of analysis in order to promote effective clinical treatments and intervention efforts for survivors. An example for such an effort could be to utilize models of dynamic cellular markers as individual-level factors to account for variation in intervention response and clinical outcomes. Results of this study will lead to new knowledge about specific gene expression pathways in response to stress, and whether the response is moderated by previous exposure to early adversity, shorter telomere length (a marker of cellular aging) and self-report mental-health measures. Thus, the long-term effects of this study will advance our understanding on stress-related transcriptomic changes that play a downstream role in disease susceptibility and accelerated aging, with the goal of targeting specific pathways and genes for potential intervention studies and pharmacological treatments to reverse the effects of exposure to early adversity. For example, considering high failure rates for depression treatments, and in order to tailor individual interventions, identifying objective changes in stress-induced gene expression may help to predict intervention efficacy in clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers. Thus, findings will have a range of impacts for basic science, intervention studies and clinical practice that will influence treatments to match the specific cellular processes operating within an individual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-25
  • •Without significant medical illness or endocrine illness (for example, asthma, diabetes, thyroid disease or pituitary gland disorders)
  • •Currently non-smokers
  • •Not pregnant and had not given birth in the past year
  • •Not using medication on a regular basis besides oral contraceptives to allow generalizability to adult women.

排除标准

  • •Recent infection or illness
  • •Use of abused drugs
  • •Immune disease, ascertained during the phone interview.

研究组 & 干预措施

Experimental design

Experimental

Testing will be carried out in Penn State's Clinical Research Center (CRC). The CRC has rooms for conducting the Trier Social Stress Test (TSST) stress-task and for resting. Participants will make two visits to the CRC, one week apart, on the same day of the weekday. Sessions will be scheduled from 11:00 am to 4:15 pm. We will use a randomized counter-balanced order for the two sessions (i.e., TSST and control conditions) with group membership blind to the subjects and lab personnel.

干预措施: Behavioral (Behavioral)

Control design

Experimental

In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).

干预措施: Control condition (Behavioral)

结局指标

主要结局

Gene expression via RNAseq

时间窗: Gene expression over 5 hours in response to stress or a no-stress condition

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

Idan Shalev

Assistant Professor

Penn State University

研究点 (1)

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