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Differing Levels of Hypoglycemia
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Differing Levels of Hypoglycemia
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: • Body mass index \>21kg · m-2 Exclusion Criteria: * 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 Physical Exam Exclusion Criteria * Uncontrolled severe hypertension (i.e., 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 (study visit) * Hepatic failure / jaundice * Renal failure * Cerebrovascular accident occurrence or hospitalization within 4 weeks prior to enrollment * Fever greater than 38.0 degrees C Screening Laboratory Tests Exclusion Criteria * Hematocrit lower than 32 % * White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul * Liver function tests: serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) greater than twice upper limit of normal range * Alkaline phosphatase greater than 150U/L * Total bilirubin (TBil) greater than 2 mg/dl * Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 * Positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C * Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)
About the study
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.
What is being tested
- Glucose clamp (device)
Sponsor: University of Maryland, Baltimore · Participants: 32 · Started: 2015-07
Contact the study team
- Maka Siamashvili, MD · Phone: 410-706-5623
Official record on ClinicalTrials.gov — NCT02445781
Locations in the U.S.
| Maryland | University of Maryland, Baltimore, Baltimore University of Maryland, Baltimore, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.