NCT01816893
Completed
Not Applicable
Hypoglycemia and Autonomic Nervous System Function
Brigham and Women's Hospital2 sites in 1 country22 target enrollmentStarted: June 8, 2004Last updated:
ConditionsHypoglycemia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Change in Baroreflex Sensitivity
Overview
Brief Summary
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Baroreflex Sensitivity
Time Frame: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline
The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 \[assessed 16 hours after the clamp\] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 \[baseline assessment on the day prior to the clamp\]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.
Secondary Outcomes
- Muscle Sympathetic Nerve Activity(16 hours after euglycemic and hypoglycemic clamps)
- Catecholamine Response to Lower-body Negative Pressure(16 hours after euglycemic and hypoglycemic clamps)
Investigators
Gail Adler
Associate Professor of Medicine
Brigham and Women's Hospital
Study Sites (2)
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