Dose Response of Epinephrine (NCT02692313) | Clinical Trial Compass
CompletedEarly Phase 1
Dose Response of Epinephrine
United States32 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Pos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Flow mediated dilation (FMD) of the brachial artery
Timeframe: From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))