Temporal Genomics Mechanisms Underlying Disease and Aging

Sponsor

Penn State University (Other)

Overall Status

Completed

CT.gov ID

NCT03637751

Collaborator

(none)

Enrollment

Location

Arms

34.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gene Expression in Response to Acute Stress	Behavioral: Behavioral Behavioral: Control condition	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Temporal Genomics Mechanisms Underlying Disease and Aging

Actual Study Start Date :

Aug 21, 2018

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental design 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.	Behavioral: Behavioral Trier Social Stress Test
Experimental: Control design 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).	Behavioral: 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).

Arm

Intervention/Treatment

Experimental: Experimental design

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.

Behavioral: Behavioral

Trier Social Stress Test

Experimental: Control design

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).

Behavioral: 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).

Outcome Measures

Primary Outcome Measures

Gene expression via RNAseq [Gene expression over 5 hours in response to stress or a no-stress condition]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biobehavioral Health Building	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Idan Shalev, Assistant Professor, Penn State University

ClinicalTrials.gov Identifier:

NCT03637751

Other Study ID Numbers:

1R21AG055621-01A1

First Posted:

Aug 20, 2018

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 28, 2021