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.
Conditions:
๐Ÿฆ  Diabetes Complications
๐Ÿ—“๏ธ Study Start (Actual) June 2016
๐Ÿ—“๏ธ Primary Completion (Estimated) February 2025
โœ… Study Completion (Estimated) February 2025
๐Ÿ‘ฅ Enrollment (Estimated) 32
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase EARLY_PHASE1
Locations:
๐Ÿ“ Baltimore, Maryland, United States

๐Ÿ“‹ Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 February 2016
  • First Submitted that Met QC Criteria 22 February 2016
  • First Posted 26 February 2016

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 March 2024
  • Last Update Posted 6 March 2024
  • Last Verified March 2024