Status:
COMPLETED
The Functional Neuroanatomy of the Human Physiological Stress Response
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Boston Children's Hospital
Conditions:
Hypoglycemia
Physiological Stress
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Stress is common in daily life and is associated with adverse health outcomes. This proposal will study how a physiological stress (low blood sugar), a stress often experienced by people with diabetes...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Males and Females age 18 to 45 years
- BMI 18-35 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03867344
Start Date
October 1 2019
End Date
December 30 2025
Last Update
January 5 2026
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115