N/A
N=22
Hypoglycemia and Autonomic Nervous System Function
Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01816893 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Change in Baroreflex Sensitivity — 2.3; -1.6 ms/mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypoglycemic hyperinsulinemic clamp (Other); Euglycemic hyperinsulinemic clamp (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baroreflex Sensitivity |
2.3; -1.6 | — |
| SECONDARY Muscle Sympathetic Nerve Activity |
33.64; 26.4; 53.4; 40.1 | — |
| SECONDARY Catecholamine Response to Lower-body Negative Pressure |
3.0; 2.0 | — |
Summary
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
- Males and females age 18 to 50 years
Exclusion Criteria
- Pregnancy
- Lactation
- Subjects who smoke or are on other forms of nicotine will be excluded
- Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
- Current major depressive illness
- 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 thyroxine
Data sourced from ClinicalTrials.gov (NCT01816893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.