Temporal Genomics Mechanisms Underlying Disease and Aging

Gene Expression in Response to Acute Stress Clinical Trial

Official title:

Temporal Genomics Mechanisms Underlying Disease and Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637751
• Other study ID #: 1R21AG055621-01A1
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Recent infection or illness

• Use of abused drugs

• Immune disease, ascertained during the phone interview.

Related Conditions & MeSH terms

• Gene Expression in Response to Acute Stress

Intervention

Behavioral:
• Behavioral
Trier Social Stress Test
• Control condition
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).

Locations

Country	Name	City	State
United States	Biobehavioral Health Building	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression via RNAseq		Gene expression over 5 hours in response to stress or a no-stress condition