COMPLETED

The Functional Neuroanatomy of the Human Physiological Stress Response

Conditions

Hypoglycemia Physiological Stress Stress Brain

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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 purpose of this study is to examine the effect of a moderately low blood sugar stress on the nervous system. The investigators hope that information obtained from completing this study will help to reveal information about how a non-psychological stress impacts the parts of the brain that react to stress and the autonomic nervous system. The autonomic nervous system is the part of the nervous system that provides the body with involuntary or automatic control of heart rate, blood pressure, and breathing.

Official Title

The Functional Neuroanatomy of the Human Physiological Stress Response

Quick Facts

Study Start:2019-10-01

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03867344

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:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy volunteers * Males and Females age 18 to 45 years * BMI 18-35 kg/m2	* Pregnancy * Lactation * Menopause * Any medical condition * Current or prior alcohol or drug abuse * Active tobacco use * Abnormal ECG * In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded. * Use of medications other than thyroid hormone or hormonal birth control * Serum potassium \>5.0 mmol/L * Estimated GFR \<60 mL/min/1.73 m2 * Hemoglobin A1c ≥6.5% * Patient Health Questionnaire (PHQ9) for depression score ≥15 * GAD-7 Questionnaire for anxiety score ≥10 * PTSD Checklist for DSM-5 (PCL-5) score ≥31 * Perceived Stress Scale (PSS-14) score \>28 * Blood pressure systolic ≥140 or \<100 mmHg; Blood pressure diastolic \>90 mmHg * Metal in the body including: cardiac pacemakers, stents, artificial heart valves, artificial limbs or hands, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others), other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal medication patches, and metal-containing IUDs

Inclusion Criteria

Exclusion Criteria

* Healthy volunteers
* Males and Females age 18 to 45 years
* BMI 18-35 kg/m2

* Pregnancy
* Lactation
* Menopause
* Any medical condition
* Current or prior alcohol or drug abuse
* Active tobacco use
* Abnormal ECG
* In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Use of medications other than thyroid hormone or hormonal birth control
* Serum potassium \>5.0 mmol/L
* Estimated GFR \<60 mL/min/1.73 m2
* Hemoglobin A1c ≥6.5%
* Patient Health Questionnaire (PHQ9) for depression score ≥15
* GAD-7 Questionnaire for anxiety score ≥10
* PTSD Checklist for DSM-5 (PCL-5) score ≥31
* Perceived Stress Scale (PSS-14) score \>28
* Blood pressure systolic ≥140 or \<100 mmHg; Blood pressure diastolic \>90 mmHg
* Metal in the body including: cardiac pacemakers, stents, artificial heart valves, artificial limbs or hands, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others), other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal medication patches, and metal-containing IUDs

Contacts and Locations

Principal Investigator

Roy Freeman, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Gail K Adler, MD, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

David Borsook, MD, PhD

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Roy Freeman, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center
Gail K Adler, MD, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
David Borsook, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

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 Date2019-10-01

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2019-10-01

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Hypoglycemia
Stress
Brain

Additional Relevant MeSH Terms

Hypoglycemia
Physiological Stress