Dose Response of Epinephrine

Diabetes Complications Clinical Trial

— Epineprhine  

Official title:

Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02692313
• Other study ID #: HP-00068487
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 2016
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Maka Siamashvili, MD
• Phone: 410-706-5623
• Email: msiamashvili[@]medicine.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Complications

Intervention

Drug:
• Epinephrine
Dose response of epinephrine infusion

Other:
• Saline infusion
Placebo

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))