Skeletal Muscle Fatigue in HumansNCT02712658
Role of K+ and Ca2+ in Development of Muscle Fatigue
A study testing Terbutaline in people with Skeletal Muscle Fatigue in Humans, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Fatigue in Humans
- What is being tested?
- Terbutaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Mar 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- physical active healthy men
- aged 18-40 years
Who cannot join
- smokers
- allergy towards terbutaline
- chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men.
- Conditions
- Skeletal Muscle Fatigue in Humans
- Being tested
- Terbutaline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbutalineDrug
K+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| terbutaline | Active comparator | terbutaline is administered by injection (0.25-0.5 mg Bricanyl, AstraZeneca diluted in 9 ml isotonic saline) Receives: Drug: Terbutaline |
| Placebo | Placebo comparator | placebo is administered as isotonic saline (10 ml) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to fatigue during knee-extensor exercise
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Fatigue in HumansStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Nielsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712658
- Sponsor's protocol ID
- MIK
- Status last verified
- Jan 2017
- First submitted
- 11 Oct 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of K+ and Ca2+ in Development of Muscle Fatigue
- ClinicalTrials.gov ID
- NCT02712658
- Acronym / sponsor ID
- MIK
- Conditions
- Skeletal Muscle Fatigue in Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Mar 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.
The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| terbutaline | Active comparator | Drug: Terbutalineterbutaline is administered by injection (0.25-0.5 mg Bricanyl, AstraZeneca diluted in 9 ml isotonic saline) |
| Placebo | Placebo comparator | Drug: Placeboplacebo is administered as isotonic saline (10 ml) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- physical active healthy men
- aged 18-40 years
Key exclusion criteria (3 listed)
- smokers
- allergy towards terbutaline
- chronic disease
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 |
|---|---|---|
| TerbutalineK+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline | Drug | terbutaline |
| Placebo | Drug | Placebo |
Primary outcome
Change in time to fatigue during knee-extensor exercise
Time frame: 1 day
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 31 Jan 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terbutaline in people with Skeletal Muscle Fatigue in Humans, run by University of Copenhagen 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 2 inclusion and 3 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 31 Jan 2017. 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. 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.
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?
Change in time to fatigue during knee-extensor exercise (time frame: 1 day). 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 31 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.