Effects of epinephrine on blood vessel function in healthy individuals

Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine

This study tests how different amounts of epinephrine affect blood vessel function and inflammation in healthy adults aged 18-55.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT02692313 on ClinicalTrials.gov

What this trial studies

This study investigates how different doses of epinephrine, a hormone that helps regulate blood sugar levels, affect endothelial function and inflammatory mechanisms in healthy adults. By administering epinephrine and saline infusions, researchers aim to understand its role in counterregulating hypoglycemia and its potential impact on cardiovascular health. The study focuses on healthy individuals aged 18-55 with a body mass index greater than 21 kg/m², excluding those with certain health conditions or on specific medications.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-55 with a body mass index greater than 21 kg/m².

Not a fit: Patients with significant cardiovascular issues, uncontrolled hypertension, or those on anticoagulant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how epinephrine influences cardiovascular health and diabetes management.

How similar studies have performed: While the specific dose-response effects of epinephrine on endothelial function are less explored, related studies on epinephrine's role in diabetes management have shown promising results.

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)

Where this trial is running

Baltimore, Maryland

• University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Stephen Davis, MBBS — University of Maryland, Baltimore
• Study coordinator: Maka Siamashvili, MD

Conditions Diabetes Complications; epinephrine; counterregulation; dose responses