COMPLETED

Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline

Conditions

Middle-aged Adults Major Depressive Disorder intradermal microdialysis microvascular function endothelium-dependent dilation nitric oxide stress cognitive function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this pilot clinical trial is to begin to understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete a 15-day testing cycle. During this cycle, participants will complete daily assessments of stress using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.

Official Title

Accelerated Vascular Aging in Midlife as a Mechanism Linking Daily Stress to Cognitive Decline

Quick Facts

Study Start:2024-05-30

Study Completion:2025-05-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06466655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females aged 40-55 yrs * Absence of objective cognitive impairment (≥26 on the Montreal Cognitive Assessment) * Absence of diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases, as determined by medical history, physical examination, blood chemistries, and 12-lead resting electrocardiogram * Participants must have a level of understanding of the English language sufficient to provide informed consent and to agree to all tests and procedures, as well as the capacity and willingness to attend all study related visits and to comply with the study protocol	* \<40 or \>55 yrs * Psychiatric illness aside from MDD (e.g., bipolar disorder, schizophrenia, eating disorders), assessed by the MINI and self-report * Objective cognitive impairment (\<26 on the Montreal Cognitive Assessment) * Diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases * Current or recent use (within 8 wks) of medications that alter cardiovascular function or psychoactive/psychopharmacological drugs * Body mass index ≥35 kg/m2 * Resting systolic BP ≥140 mmHg * HbA1c ≥5.7% * Direct low-density lipoprotein ≥160mg/dl * Tobacco use (including electronic cigarettes) * Females who are pregnant, breastfeeding, or planning to become pregnant; female subjects of child-bearing age must have a negative urine pregnancy test on the day of all experimental visits * Current or past use of hormone replacement therapy * Allergy to study drugs or pharmacological agents

Inclusion Criteria

Exclusion Criteria

* Males and females aged 40-55 yrs
* Absence of objective cognitive impairment (≥26 on the Montreal Cognitive Assessment)
* Absence of diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases, as determined by medical history, physical examination, blood chemistries, and 12-lead resting electrocardiogram
* Participants must have a level of understanding of the English language sufficient to provide informed consent and to agree to all tests and procedures, as well as the capacity and willingness to attend all study related visits and to comply with the study protocol

* \<40 or \>55 yrs
* Psychiatric illness aside from MDD (e.g., bipolar disorder, schizophrenia, eating disorders), assessed by the MINI and self-report
* Objective cognitive impairment (\<26 on the Montreal Cognitive Assessment)
* Diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases
* Current or recent use (within 8 wks) of medications that alter cardiovascular function or psychoactive/psychopharmacological drugs
* Body mass index ≥35 kg/m2
* Resting systolic BP ≥140 mmHg
* HbA1c ≥5.7%
* Direct low-density lipoprotein ≥160mg/dl
* Tobacco use (including electronic cigarettes)
* Females who are pregnant, breastfeeding, or planning to become pregnant; female subjects of child-bearing age must have a negative urine pregnancy test on the day of all experimental visits
* Current or past use of hormone replacement therapy
* Allergy to study drugs or pharmacological agents

Contacts and Locations

Principal Investigator

Jody Greaney, PhD

PRINCIPAL_INVESTIGATOR

University of Delaware

Study Locations (Sites)

University of Delaware

Newark, Delaware, 19713

United States

Collaborators and Investigators

Sponsor: University of Delaware

Jody Greaney, PhD, PRINCIPAL_INVESTIGATOR, University of Delaware

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30

Study Completion Date2025-05-29

Study Record Updates

Study Start Date2024-05-30

Study Completion Date2025-05-29

Terms related to this study

Keywords Provided by Researchers

intradermal microdialysis
microvascular function
endothelium-dependent dilation
nitric oxide
stress
cognitive function

Additional Relevant MeSH Terms

Middle-aged Adults
Major Depressive Disorder