Beta2-adrenergic Agonism and Muscle Remodelling
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
1 other identifier
interventional
72
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedMarch 25, 2020
March 1, 2020
2.9 years
June 7, 2018
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proteome enrichment
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
Baseline and 6 weeks
Secondary Outcomes (2)
Body composition
Baseline, 2 weeks, 4 weeks and 6 weeks
Maximal oxygen consumption (VO2max)
Baseline, 2 weeks, 4 weeks and 6 weeks
Other Outcomes (1)
Drug exposure
Day 1-14 and day 49-56
Study Arms (3)
Control
PLACEBO COMPARATORSubjects receive placebo treatment
Long acting beta2-agonist
EXPERIMENTALSubjects are treated with long-acting beta2-agonist formoterol
Short acting beta2-agonist
EXPERIMENTALSubjects are treated with short-acting beta2-agonist terbutaline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
August Krogh Building
Copenhagen, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 21, 2018
Study Start
June 25, 2018
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
March 25, 2020
Record last verified: 2020-03