COMPLETED

Dose Response of Epinephrine

Conditions

Diabetes Complications epinephrine counterregulation dose responses

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine

Quick Facts

Study Start:2016-06

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02692313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* healthy controls age 18-55 yr. * Body mass index \>21 kg · m-2	* 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)

Inclusion Criteria

Exclusion Criteria

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

* 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)

Contacts and Locations

Principal Investigator

Stephen Davis, MBBS

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland, Baltimore

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Stephen Davis, MBBS, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06

Study Completion Date2025-09

Study Record Updates

Study Start Date2016-06

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

epinephrine
counterregulation
dose responses

Additional Relevant MeSH Terms

Diabetes Complications