Examining how low blood sugar affects the brain's stress response

The Functional Neuroanatomy of the Human Physiological Stress Response

This study is trying to see how low blood sugar affects the brain's response to stress and how that might impact heart function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT03867344 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of low blood sugar on the nervous system, particularly focusing on how this physiological stress alters brain connections involved in autonomic control of cardiovascular function. By using a novel mechanistic approach, the researchers will assess the response to insulin-induced hypoglycemia and its effects on brain circuitry and physiological outcomes. The study aims to define the magnitude of stress exposure on neural networks and how recovery from this stress relates to cardiovascular autonomic function.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 45 with a BMI between 18 and 35 kg/m2.

Not a fit: Patients with medical conditions, those who are pregnant or lactating, or individuals with a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of stress responses in individuals with diabetes and lead to improved management strategies for hypoglycemia.

How similar studies have performed: While the approach is novel, similar studies have explored stress responses, but this specific focus on hypoglycemia's effects on brain networks is less common.

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

Where this trial is running

Boston, Massachusetts and 1 other locations

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Roy Freeman, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Gail K Adler, MD, PhD

Conditions: Hypoglycemia, Physiological Stress, Stress, Brain