Differing Levels of Hypoglycemia
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Differing Levels of Hypoglycemia
University of Maryland, Baltimore
32 participants
Jul 1, 2015
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Body mass index >21kg · m-2
Exclusion Criteria22
- 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 (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
- 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)
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Interventions
Different levels of hypoglycemia
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT02445781