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Dose Response of Epinephrine (Epineprhine)

Primary Purpose

Diabetes Complications

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epinephrine
Saline infusion
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring epinephrine, counterregulation, dose responses

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Maryland, BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Saline infusion

Epinephrine infusion-0.015ug/kg/min

Epinephrine infusion-0.03 ug/kg/min

Epinephrine infusion-0.06 ug/kg/min

Arm Description

Hyperinsulinemic euglycemic glucose clamp with saline infusion

Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min

Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min

Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2016
Last Updated
February 10, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02692313
Brief Title
Dose Response of Epinephrine
Acronym
Epineprhine
Official Title
Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
epinephrine, counterregulation, dose responses

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline infusion
Arm Type
Placebo Comparator
Arm Description
Hyperinsulinemic euglycemic glucose clamp with saline infusion
Arm Title
Epinephrine infusion-0.015ug/kg/min
Arm Type
Experimental
Arm Description
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min
Arm Title
Epinephrine infusion-0.03 ug/kg/min
Arm Type
Experimental
Arm Description
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min
Arm Title
Epinephrine infusion-0.06 ug/kg/min
Arm Type
Experimental
Arm Description
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
Adrenaline
Intervention Description
Dose response of epinephrine infusion
Intervention Type
Other
Intervention Name(s)
Saline infusion
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Flow mediated dilation (FMD) of the brachial artery
Description
Measurements of FMD will be taken at baseline (pre intervention) and end of glucose clamp (post intervention) and the maximal % change determined
Time Frame
From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maka Siamashvili, MD
Phone
410-706-5623
Email
msiamashvili@medicine.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maia Mikeladze, MD
Phone
410-706-5626
Email
mmikeladze@medicine.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Davis, MBBS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maka Siamashvili, MD
Phone
410-706-5643
Phone
410-706-5636
First Name & Middle Initial & Last Name & Degree
Stephen N Davis, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose Response of Epinephrine

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