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Epineprhine: Dose Response of Epinephrine

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT02692313
Collaborator
Vanderbilt University (Other)
32
Enrollment
1
Location
4
Arms
102
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Maryland, Baltimore Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • Vanderbilt University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephen N. Davis, MBBS, Chairman of Medicine, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT02692313
    Other Study ID Numbers:
    • HP-00068487
    First Posted:
    Feb 26, 2016
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Stephen N. Davis, MBBS, Chairman of Medicine, University of Maryland, Baltimore
    epinephrine
    counterregulation
    dose responses
    Additional relevant MeSH terms:
    Diabetes Complications
    Epinephrine

    Study Results

    No Results Posted as of Apr 12, 2022