Dose Response of Epinephrine



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:2/2/2019
Start Date:June 2016
End Date:December 2019
Contact:Donna Tate
Email:dtate@medicine.umaryland.edu
Phone:410-706-5643

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Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine

Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer
duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo endothelial
function and atherothrombotic balance in humans. The specific aim of our study will be to
determine the dose response effects of the key ANS counterregulatory hormone epinephrine on
endothelial function, fibrinolytic balance and pro-atherogenic inflammatory mechanisms in
healthy humans.


Inclusion Criteria:

- healthy controls age 18-55 yr.

- Body mass index >21 kg · m-2

Exclusion Criteria:

- Pregnant or breastfeeding 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)
We found this trial at
1
site
621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Principal Investigator: Stephen N Davis, MBBS
Phone: 410-706-5643
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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