Status:
COMPLETED
Hypoglycemia and Autonomic Nervous System Function-B
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypoglycemia
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This study tests the hypothesis that, compared to prior normal blood sugar, prior low blood sugar impairs cardiovascular autonomic function. The proposed studies will also test the hypothesis that the...
Detailed Description
This study involves three interventions, which are performed in random order. Each intervention involves a 3-day inpatient visit. There is a space of 1-3 months between interventions. The three interv...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Males and females age 18 to 55 years
Exclusion
- Pregnancy
- Lactation
- 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
- 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 thyroxine
- Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
- Blood pressure \> 140/90 mmHg
- Creatinine \> 1.5 mg/dL
- Serum potassium \>5.2 mmol/L
- Estimated GFR \< 50 mL/min
- Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
Key Trial Info
Start Date :
July 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03429946
Start Date
July 17 2013
End Date
November 25 2025
Last Update
January 2 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