Dose Response of Epinephrine

Early Phase 1

Recruiting

• Conditions: Diabetes Complications
• Interventions: Other: Saline infusion; Drug: Epinephrine

• Registration Number: NCT02692313
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline infusion	Saline infusion	Hyperinsulinemic euglycemic glucose clamp with saline infusion
Epinephrine infusion-0.06 ug/kg/min	Epinephrine	Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min
Epinephrine infusion-0.015ug/kg/min	Epinephrine	Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min
Epinephrine infusion-0.03 ug/kg/min	Epinephrine	Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States