Clinical Trials Directory

Trials / Completed

CompletedNCT03867344

The Functional Neuroanatomy of the Human Physiological Stress Response

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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 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.

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, affects connections in the brain. The investigators will focus on brain connections that are involved in autonomic control of cardiovascular function, and determine both how these brain connections are altered by low blood sugar and how these alterations associate with changes in pain perception and cardiovascular control. In this study, the investigators introduce a novel mechanistic, integrative approach to the assessment of the response to and recovery from a specific physiologic stressor - insulin-induced hypoglycemia. The overall hypothesis is that a hypoglycemic stress will alter autonomic brain networks, and will affect clinically relevant physiological outcomes (cardiovascular autonomic function); and that the rate and extent of recovery of these brain networks will provide a measure of resilience. In combination, this approach will allow the investigators for the first time to define the magnitude of the effect of stress exposure on neural circuitry and on clinically relevant stress-related physiological outcomes (cardiovascular autonomic function) and to define the recovery of brain circuitry and these related physiological outcomes.

Conditions

Interventions

TypeNameDescription
OTHERHypoglycemic Hyperinsulinemic ClampParticipants undergo a 120-minute hypoglycemic hyperinsulinemic clamp procedure.
OTHERNormoglycemic Hyperinsulinemic ClampParticipants undergo a 120-minute normoglycemic hyperinsulinemic clamp procedure.

Timeline

Start date
2019-10-01
Primary completion
2025-12-30
Completion
2025-12-30
First posted
2019-03-08
Last updated
2026-01-05

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03867344. Inclusion in this directory is not an endorsement.