Diabetes ComplicationsEarly Phase 1EpineprhineNCT02692313
Dose Response of Epinephrine
A Early Phase 1 study testing Epinephrine and Saline infusion in people with Diabetes Complications, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Epinephrine and Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy controls age 18-55 yr.
- Body mass index >21 kg · m-2
Who cannot join
- 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
Show all 24Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: 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.
- Conditions
- Diabetes Complications
- Being tested
- Epinephrine, Saline infusion
- Keywords
- epinephrine, counterregulation, dose responses
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Adrenaline
Dose response of epinephrine infusion
Saline infusionOther
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Saline infusion | Placebo comparator | Hyperinsulinemic euglycemic glucose clamp with saline infusion Receives: Other: Saline infusion |
| Epinephrine infusion-0.015ug/kg/min | Experimental | Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min Receives: Drug: Epinephrine |
| Epinephrine infusion-0.03 ug/kg/min | Experimental | Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min Receives: Drug: Epinephrine |
| Epinephrine infusion-0.06 ug/kg/min | Experimental | Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline (pre glucose clamp) to end of experiment (time 240 minutes- 2 hours post intervention (glucose clamp))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2025
- Study completionSep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
- Investigators
- Stephen Davis, MBBS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692313
- Sponsor's protocol ID
- HP-00068487
- Acronym
- Epineprhine
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2016
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine
- ClinicalTrials.gov ID
- NCT02692313
- Acronym / sponsor ID
- Epineprhine / HP-00068487
- Conditions
- Diabetes Complications
- Keywords
- epinephrine, counterregulation, dose responses
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Jun 2016
- Primary completion
- Sep 2025 (actual)
- Study completion
- Sep 2025 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline infusion | Placebo comparator | Other: Saline infusionHyperinsulinemic euglycemic glucose clamp with saline infusion |
| Epinephrine infusion-0.015ug/kg/min | Experimental | Drug: EpinephrineHyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.015 ug/kg/min |
| Epinephrine infusion-0.03 ug/kg/min | Experimental | Drug: EpinephrineHyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.03 ug/kg/min |
| Epinephrine infusion-0.06 ug/kg/min | Experimental | Drug: EpinephrineHyperinsulinemic euglycemic glucose clamp with epinephrine infusion of 0.06 ug/kg/min |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy controls age 18-55 yr.
- Body mass index >21 kg · m-2
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpinephrineAlso: AdrenalineDose response of epinephrine infusion | Drug | Epinephrine infusion-0.015ug/kg/min, Epinephrine infusion-0.03 ug/kg/min, Epinephrine infusion-0.06 ug/kg/min |
| Saline infusionAlso: PlaceboPlacebo | Other | Saline infusion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Davis, MBBS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Epinephrine and Saline infusion in people with Diabetes Complications, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.