- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692313
Dose Response of Epinephrine (Epineprhine)
March 5, 2024 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore
Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maka Siamashvili, MD
- Phone Number: 410-706-5623
- Email: msiamashvili@medicine.umaryland.edu
Study Contact Backup
- Name: Maia Mikeladze, MD
- Phone Number: 410-706-5626
- Email: mmikeladze@medicine.umaryland.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland, Baltimore
-
Principal Investigator:
- Stephen N Davis, MBBS
-
Contact:
- Maka Siamashvili, MD
- Phone Number: 410-706-5643
-
Contact:
- Phone Number: 410-706-5636
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Saline infusion
Hyperinsulinemic euglycemic glucose clamp with saline infusion
|
Placebo
Other Names:
|
Experimental: Epinephrine infusion-0.015ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min
|
Dose response of epinephrine infusion
Other Names:
|
Experimental: Epinephrine infusion-0.03 ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min
|
Dose response of epinephrine infusion
Other Names:
|
Experimental: Epinephrine infusion-0.06 ug/kg/min
Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min
|
Dose response of epinephrine infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow mediated dilation (FMD) of the brachial artery
Time Frame: 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
|
From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephen Davis, MBBS, 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 Major Dates
Study Start
June 1, 2016
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
February 10, 2016
First Submitted That Met QC Criteria
February 22, 2016
First Posted (Estimated)
February 26, 2016
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Complications
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- HP-00068487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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