Dose Response of Epinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2025-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Saline infusion

Hyperinsulinemic euglycemic glucose clamp with saline infusion

Group Type PLACEBO_COMPARATOR

Saline infusion

Intervention Type OTHER

Placebo

Epinephrine infusion-0.015ug/kg/min

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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Dose response of epinephrine infusion

Epinephrine infusion-0.03 ug/kg/min

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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Dose response of epinephrine infusion

Epinephrine infusion-0.06 ug/kg/min

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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Dose response of epinephrine infusion

Interventions

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Epinephrine

Dose response of epinephrine infusion

Intervention Type DRUG

Saline infusion

Placebo

Intervention Type OTHER

Other Intervention Names

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Adrenaline Placebo

Eligibility Criteria

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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

* 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 %
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes