Clinical trial NCT02933203: Genetic Biomarkers of Executive Stress
Official title: Genetic Biomarkers of Executive Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 subjects - individuals who hold executive-level positions. Participants are males and females, 18 or older, may be of any ethnic background. The investigators aim to recruit a diverse sample, reflective of the broader population.

Brief summary: The purpose of this study is to examine whether stress predicts telomere length in individuals who hold executive-level positions. Telomeres are the caps at the end of each strand of DNA that may affect how cells age. Subjects will complete an online survey/interview and provide one blood sample or saliva samples. The goal is to understand whether stress predicts genetic markers of longevity.

Detailed description: The primary aim of this study is to evaluate the relationship between overall levels of stress and telomere length. It is hypothesized that the high stress group (based on the Perceived Stress Scale)compared to low stress group will have shorter telomere length. A secondary aim is to evaluate whether different types of stress have differing degrees of association with telomere length. An exploratory aim is to assess for gender differences in the association between stress and telomere length. The investigators are collecting a number of other measures, including demographics, work sector, perceived social support, and medical history, in order to adjust for potential confounders in the analysis.

This study is an extension of earlier work Dr. Rasgon has done with Dr. Elizabeth Blackburn at UCSF on the relationship between telomere length and mood outcomes. The investigators hope this study will add to the growing body of literature on stress and genetic markers of longevity, specifically how stress level and type is associated with telomere length. The increased understanding gained through this study may provide leads for predicting age-related diseases and early mortality in adults, thus benefiting others in the future.

Eligibility criteria: Inclusion Criteria:

1. People of either gender \>18 years of age.
2. Subject hold executive-level position as defined as meeting the following criteria: having managerial responsibility over an organization or substantial part of an organization and/or having strategic influence over the direction of the organization
3. Subject or representative is willing to sign the consent for prior to enrollment into the study, and to participate in all aspects of the study. Prospective subject must give verbal assent if unable to sign written consent.
4. Adequate visual acuity to complete questionnaires.

Exclusion Criteria:

1. Subjects will be excluded if they have any of the following medical conditions:

   1. active heart disease
   2. acute psychiatric disorder (hospitalized in the past year)
   3. any medical condition deemed exclusionary by the Principal Investigator (PI)
2. Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within one year prior to screening.
3. Subject is currently taking any medication deemed exclusionary by PI.
4. Subject is pregnant, lactating, or planning to become pregnant during the study period.
5. Subject is participating or has participated in another research study within 30 days prior to the screening visit.

Primary outcomes:
measure: Telomere Length
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Natalie Rasgon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: