Muscle Hypertrophy in Healthy Young MenNCT02551276
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
A study testing Salbutamol and Resistance training in people with Muscle Hypertrophy in Healthy Young Men, run by University of Copenhagen.
Trial summary
Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. 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
- Muscle Hypertrophy in Healthy Young Men
- What is being tested?
- Salbutamol and Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2015
- 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
- Non-smokers
- Non-asthmatics
- No chronic diseases
- Informed consent
Who cannot join
- Smoker
- Allergy towards study drug
About this study
Official title: Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men
Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.
- Conditions
- Muscle Hypertrophy in Healthy Young Men
- Being tested
- Salbutamol, Placebo, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
PlaceboDrug
Resistance trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks Receives: Drug: Salbutamol; Other: Resistance training |
| Control | Placebo comparator | Placebo and resistance training for 10 weeks Receives: Drug: Placebo; Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Hypertrophy (lean body mass in Kilograms)
Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)
Measured: 2 days
Secondary outcomes (1)
Left Ventricular Hypertrophy (mass in grams)
Left Ventricular Mass (g) will be measured by echocardiography of the heart
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 posted16 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Hypertrophy in Healthy Young MenStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Southern Denmark
- Responsible party
- Principal investigator, Morten Nielsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551276
- Sponsor's protocol ID
- SAL-STYRKE
- Status last verified
- Mar 2016
- First submitted
- 12 Sep 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men
- ClinicalTrials.gov ID
- NCT02551276
- Acronym / sponsor ID
- SAL-STYRKE
- Conditions
- Muscle Hypertrophy in Healthy Young Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Southern Denmark
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Sep 2015 (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.
Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Salbutamol, Other: Resistance trainingBeta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks |
| Control | Placebo comparator | Drug: Placebo, Other: Resistance trainingPlacebo and resistance training for 10 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Physical active
- Non-smokers
- Non-asthmatics
- No chronic diseases
- Informed consent
Key exclusion criteria (2 listed)
- Smoker
- Allergy towards study drug
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 |
|---|---|---|
| Salbutamol | Drug | Experimental |
| Placebo | Drug | Control |
| Resistance training | Other | Control, Experimental |
Primary outcome
Skeletal Muscle Hypertrophy (lean body mass in Kilograms)
Time frame: 2 days
Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)
1 secondary outcome
Left Ventricular Hypertrophy (mass in grams)
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 15 Mar 2016.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol and Resistance training in people with Muscle Hypertrophy in Healthy Young Men, run by University of Copenhagen.
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 5 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Skeletal Muscle Hypertrophy (lean body mass in Kilograms) (time frame: 2 days). 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 15 Mar 2016.