Muscle Hypertrophy in Healthy Young MenNCT02557581
cAMP Signaling and Muscle Adaptations
A study testing No training, Endurance training and Resistance Training in people with Muscle Hypertrophy in Healthy Young Men, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Hypertrophy in Healthy Young Men
- What is being tested?
- No training, Endurance training and Resistance Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2015to Oct 2017
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young men
- 18-35 years of age
- Informed consent
- Active 2-5 hours of training pr. week
- Maximal oxygen uptake (ml/min/kg) of 40-60
- Lean body mass of 55-65 kg / Lean mass index 14-22 kg/m2
Who cannot join
- Smoker
- Allergy towards study drugs
- Chronic disease
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Nutrition, Exercise and Sports
Copenhagen, 2100
Morten Hostrup, PhD, +4524474785, mortenhostrup@gmail.com
- Recruiting
Bispebjerg University Hospital
Copenhagen, 2400
Morten Hostrup, PhD, +4524474785, mortenhostrup@gmail.com
About this study
The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.
- Conditions
- Muscle Hypertrophy in Healthy Young Men
- Being tested
- No training, Endurance training, Resistance Training, Terbutaline, Clenbuterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No trainingOther
Endurance trainingOther
Resistance TrainingOther
TerbutalineDrug
ClenbuterolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Terbutaline | Experimental | Beta2-adrenergic stimulation with terbutaline Receives: Other: No training; Other: Endurance training; Other: Resistance Training; Drug: Terbutaline |
| Placebo | Placebo comparator | Placebo Receives: Other: No training; Other: Endurance training; Other: Resistance Training; Drug: Placebo |
| Clenbuterol | Experimental | Beta2-adrenergic stimulation with clenbuterol Receives: Other: No training; Drug: Clenbuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Energy turnover (ml/min or mmol/kg dry weight muscle)
Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense 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 posted23 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion30 Jun 2017
- Study completionOct 2017 (estimated)
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
- 72 participants (estimated)
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
- NCT02557581
- Sponsor's protocol ID
- TUD
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cAMP Signaling and Muscle Adaptations
- ClinicalTrials.gov ID
- NCT02557581
- Acronym / sponsor ID
- TUD
- Conditions
- Muscle Hypertrophy in Healthy Young Men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 23 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.
The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terbutaline | Experimental | Other: No training, Other: Endurance training, Other: Resistance Training, Drug: TerbutalineBeta2-adrenergic stimulation with terbutaline |
| Placebo | Placebo comparator | Other: No training, Other: Endurance training, Other: Resistance Training, Drug: PlaceboPlacebo |
| Clenbuterol | Experimental | Other: No training, Drug: ClenbuterolBeta2-adrenergic stimulation with clenbuterol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy young men
- 18-35 years of age
- Informed consent
- Active 2-5 hours of training pr. week
- Maximal oxygen uptake (ml/min/kg) of 40-60
Key exclusion criteria (3 listed)
- Smoker
- Allergy towards study drugs
- 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 |
|---|---|---|
| No training | Other | Clenbuterol, Placebo, Terbutaline |
| Endurance training | Other | Placebo, Terbutaline |
| Resistance Training | Other | Placebo, Terbutaline |
| Terbutaline | Drug | Terbutaline |
| Clenbuterol | Drug | Clenbuterol |
| Placebo | Drug | Placebo |
Primary outcome
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
Energy turnover (ml/min or mmol/kg dry weight muscle)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No training, Endurance training and Resistance Training in people with Muscle Hypertrophy in Healthy Young Men, run by University of Copenhagen at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Hostrup, PhD (+4524474785, mortenhostrup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 26 Oct 2017.