HypertrophyNCT03565302
Beta2-adrenergic Agonism and Muscle Remodelling
A study testing Formoterol and Terbutaline in people with Hypertrophy and Physiologic Hypertrophy, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy, Physiologic Hypertrophy, Physical Activity
- What is being tested?
- Formoterol and Terbutaline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jun 2018to 30 May 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, aged 18-45 years
- VO2max >55 ml/kg/min for men and >50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)
- Body Mass Index (BMI) < 26
Who cannot join
- Chronic user of beta2-agonist or allergy towards study drugs
- Serious adverse side effects of the used study drug
- Chronic disease that by the project physician would affect any of the outcomes of the study
- Smoker
- Chronic use of prescription medication (other than contraceptives for women)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen
Morten Hostrup, PhD, +4524474785, mhostrup@nexs.ku.dk
About this study
Official title: Gender-specific Role of the beta2-adrenergic Stimulation With Short- or Long-acting Selective Agonist in Relation to Muscle Remodelling, Function, Performance, and Anti-doping
The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping
- Conditions
- Hypertrophy, Physiologic Hypertrophy, Physical Activity
- Being tested
- Formoterol, Terbutaline, Placebo
- Keywords
- Proteome, VO2max, Muscle function, Exercise performance, Skeletal muscle, Doping, Anti-Doping, Enantiomeric analysis
- Medical subject headings
- Hypertrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormoterolDrug
Subjects are treated with daily inhalation of formoterol
TerbutalineDrug
Subjects are treated with daily inhalation of terbutaline
PlaceboOther
Subjects are treated with placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects receive placebo treatment Receives: Other: Placebo |
| Long acting beta2-agonist | Experimental | Subjects are treated with long-acting beta2-agonist formoterol Receives: Drug: Formoterol |
| Short acting beta2-agonist | Experimental | Subjects are treated with short-acting beta2-agonist terbutaline Receives: Drug: Terbutaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteome enrichment
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Body composition
Change in body composition (measured by dual energy x ray absorptiometry)
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks
Maximal oxygen consumption (VO2max)
Change in VO2max (measured during bike ergometer cycling to exhaustion)
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start25 Jun 2018
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies 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
- 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
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565302
- Sponsor's protocol ID
- FOR/TER
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-specific Role of the beta2-adrenergic Stimulation With Short- or Long-acting Selective Agonist in Relation to Muscle Remodelling, Function, Performance, and Anti-doping
- ClinicalTrials.gov ID
- NCT03565302
- Acronym / sponsor ID
- FOR/TER
- Conditions
- Hypertrophy, Physiologic Hypertrophy, Physical Activity
- Keywords
- Proteome, VO2max, Muscle function, Exercise performance, Skeletal muscle, Doping, Anti-Doping, Enantiomeric analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 21 Jun 2018 (actual)
- 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 study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping
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 |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboSubjects receive placebo treatment |
| Long acting beta2-agonist | Experimental | Drug: FormoterolSubjects are treated with long-acting beta2-agonist formoterol |
| Short acting beta2-agonist | Experimental | Drug: TerbutalineSubjects are treated with short-acting beta2-agonist terbutaline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women, aged 18-45 years
- VO2max >55 ml/kg/min for men and >50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)
- Body Mass Index (BMI) < 26
Key exclusion criteria (6 listed)
- Chronic user of beta2-agonist or allergy towards study drugs
- Serious adverse side effects of the used study drug
- Chronic disease that by the project physician would affect any of the outcomes of the study
- Smoker
- Chronic use of prescription medication (other than contraceptives for women)
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 |
|---|---|---|
| FormoterolSubjects are treated with daily inhalation of formoterol | Drug | Long acting beta2-agonist |
| TerbutalineSubjects are treated with daily inhalation of terbutaline | Drug | Short acting beta2-agonist |
| PlaceboSubjects are treated with placebo | Other | Control |
Primary outcome
Proteome enrichment
Time frame: Baseline and 6 weeks
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
2 secondary outcomes
Body composition
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Maximal oxygen consumption (VO2max)
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formoterol and Terbutaline in people with Hypertrophy and Physiologic Hypertrophy, run by Morten Hostrup, PhD 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 3 inclusion and 6 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 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteome enrichment (time frame: Baseline and 6 weeks). 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 25 Mar 2020.