Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • healthy controls age 18-55 yr.
  • Body mass index >21 kg ยท 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)

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Saline infusion
Hyperinsulinemic euglycemic glucose clamp with saline infusion
  • Other: Saline infusion
    Placebo
    Other names:
    • Placebo
Experimental
Epinephrine infusion-0.015ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min
  • Drug: Epinephrine
    Dose response of epinephrine infusion
    Other names:
    • Adrenaline
Experimental
Epinephrine infusion-0.03 ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min
  • Drug: Epinephrine
    Dose response of epinephrine infusion
    Other names:
    • Adrenaline
Experimental
Epinephrine infusion-0.06 ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min
  • Drug: Epinephrine
    Dose response of epinephrine infusion
    Other names:
    • Adrenaline

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201
Contact:
Donna Tate
410-706-5643

More Details

NCT ID
NCT02692313
Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Donna Tate
410-706-5643
dtate@medicine.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.