Dose Response of Epinephrine (Epineprhine)

September 30, 2025 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Vanderbilt University

Investigators

  • Principal Investigator: Stephen Davis, MBBS, University of Maryland, Baltimore

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 Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimated)

February 26, 2016

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00068487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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