HealthyNCT01116609
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs
A study testing Epinephrine in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to define the local metabolic effects of epinephrine in the bilaterally perfused human leg. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epinephrine
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2004to Jan 2010
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
Who cannot join
- Comorbidity
- Females
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical research laboratories, Aarhus University Hospital
Aarhus, 8000
About this study
The purpose of this study is to define the local metabolic effects of epinephrine in the bilaterally perfused human leg.
- Conditions
- Healthy
- Being tested
- Epinephrine
- Keywords
- Phenylalanine, Palmitate, hyperinsulinemic-euglycemic-clamp, Effects of epinephrine in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Adrenaline
unilateral leg infusion of Epinephrine 0.4 micrograms/m2/min
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterio-Venous balances of metabolites
Acute regional effect of epinephrine infusion in the femoral artery
Measured: 6 hours infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startOct 2004
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Moller, Professor, Principal investigator, Medical Research Laboratories, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116609
- Sponsor's protocol ID
- Epi-perfusion
- Status last verified
- Nov 2011
- First submitted
- 9 Apr 2010
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs
- ClinicalTrials.gov ID
- NCT01116609
- Acronym / sponsor ID
- Epi-perfusion
- Conditions
- Healthy
- Keywords
- Phenylalanine, Palmitate, hyperinsulinemic-euglycemic-clamp, Effects of epinephrine in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 May 2010 (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.
The purpose of this study is to define the local metabolic effects of epinephrine in the bilaterally perfused human leg.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male
Key exclusion criteria (2 listed)
- Comorbidity
- Females
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: Adrenalineunilateral leg infusion of Epinephrine 0.4 micrograms/m2/min | Drug | – |
Primary outcome
Arterio-Venous balances of metabolites
Time frame: 6 hours infusion
Acute regional effect of epinephrine infusion in the femoral artery
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 7 Nov 2011.
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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.
Niels Moller, Professor principal investigator
Medical Research Laboratories, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine in people with Healthy, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 2 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 7 Nov 2011. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Arterio-Venous balances of metabolites (time frame: 6 hours infusion). 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 7 Nov 2011.