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OpenTrials
Completed

NCT Number: NCT02692313

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epinephrine

Drug

Dose response of epinephrine infusion

Other names: Adrenaline

Saline infusion

Other

Placebo

Other names: Placebo

Primary outcomes

  1. Flow mediated dilation (FMD) of the brachial artery

    Time frame: From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))

    Measurements of FMD will be taken at baseline (pre intervention) and end of glucose clamp (post intervention) and the maximal % change determined

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Vanderbilt University

Registry information

Official study title

Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine

Acronym: Epineprhine

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2016
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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