Actively Recruiting
Differing Levels of Hypoglycemia
Led by University of Maryland, Baltimore · Updated on 2025-11-10
32
Participants Needed
2
Research Sites
595 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
V
Vanderbilt University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.
CONDITIONS
Official Title
Differing Levels of Hypoglycemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index >21 kg/m2
You will not qualify if you...
- Pregnant women
- Subjects unwilling or unable to comply with approved contraception measures
- Subjects unable to give voluntary informed consent
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
- Current tobacco use
- Subjects with any known allergies to any of the study medications being used
- Uncontrolled severe hypertension (blood pressure greater than 160/100)
- Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia)
- Pneumonia treatment or hospitalization within 2 weeks prior to enrollment
- Hepatic failure or jaundice
- Renal failure
- Cerebrovascular accident or hospitalization within 4 weeks prior to enrollment
- Fever greater than 38.0 degrees C
- Hematocrit lower than 32 %
- White blood cell count lower than 3 thou/ul or greater than 14 thou/ul
- Liver function tests (SGOT and SGPT) greater than twice upper limit of normal
- Alkaline phosphatase greater than 150 U/L
- Total bilirubin greater than 2 mg/dl
- Estimated glomerular filtration rate less than 60 mL/min/1.73 m2
- Positive HIV, Hepatitis B or Hepatitis C
- Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
M
Maka Siamashvili, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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