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Search / Trial NCT03867344

The Functional Neuroanatomy of the Human Physiological Stress Response

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 5, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hypoglycemia Stress Brain

ClinConnect Summary

The clinical trial titled "The Functional Neuroanatomy of the Human Physiological Stress Response" is investigating how a moderately low blood sugar level affects the nervous system and the body's stress response. Researchers aim to understand how this type of physical stress influences the brain and the autonomic nervous system, which controls automatic functions like heart rate and breathing. This study hopes to increase our knowledge about how non-psychological stress impacts our body, which could have important implications for health.

To participate in this trial, you need to be a healthy adult between the ages of 18 and 45 and have a body mass index (BMI) between 18 and 35. However, certain people cannot join, such as those who are pregnant, have specific medical conditions, or use certain medications. If you qualify and decide to participate, you will undergo assessments to understand how your body responds to the stress of low blood sugar. It's a chance to contribute to important research while learning more about how stress affects your body.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Healthy volunteers
  • Males and Females age 18 to 45 years
  • BMI 18-35 kg/m2
  • Exclusion Criteria:
  • 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

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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