NCT02692313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

9.3 years

First QC Date

February 10, 2016

Last Update Submit

September 30, 2025

Conditions

Diabetes Complications

Keywords

epinephrinecounterregulationdose responses

Outcome Measures

Primary Outcomes (1)

  • 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

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

Study Arms (4)

Saline infusion

PLACEBO COMPARATOR

Hyperinsulinemic euglycemic glucose clamp with saline infusion

Other: Saline infusion

Epinephrine infusion-0.015ug/kg/min

EXPERIMENTAL

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

Drug: Epinephrine

Epinephrine infusion-0.03 ug/kg/min

EXPERIMENTAL

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

Drug: Epinephrine

Epinephrine infusion-0.06 ug/kg/min

EXPERIMENTAL

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

Drug: Epinephrine

Interventions

EpinephrineDRUG

Dose response of epinephrine infusion

Also known as: Adrenaline
Epinephrine infusion-0.015ug/kg/minEpinephrine infusion-0.03 ug/kg/minEpinephrine infusion-0.06 ug/kg/min
Saline infusionOTHER

Placebo

Also known as: Placebo
Saline infusion

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy controls age 18-55 yr.
  • Body mass index \>21 kg · m-2

You may not qualify if:

  • 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
  • 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
  • Hematocrit lower than 32 %
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Complications

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Stephen Davis, MBBS

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 26, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)