Back to resultsBeta2-adrenergic Agonism and Muscle Remodelling
Primary Purpose
Hypertrophy, Physiologic Hypertrophy, Physical Activity
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Formoterol
Terbutaline
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Hypertrophy focused on measuring Proteome, VO2max, Muscle function, Exercise performance, Skeletal muscle, Doping, Anti-Doping, Enantiomeric analysis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- August Krogh BuildingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control
Long acting beta2-agonist
Short acting beta2-agonist
Arm Description
Subjects receive placebo treatment
Subjects are treated with long-acting beta2-agonist formoterol
Subjects are treated with short-acting beta2-agonist terbutaline
Outcomes
Primary Outcome Measures
Proteome enrichment
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
Secondary Outcome Measures
Body composition
Change in body composition (measured by dual energy x ray absorptiometry)
Maximal oxygen consumption (VO2max)
Change in VO2max (measured during bike ergometer cycling to exhaustion)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03565302
Brief Title
Beta2-adrenergic Agonism and Muscle Remodelling
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Morten Hostrup, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy, Physiologic Hypertrophy, Physical Activity
Keywords
Proteome, VO2max, Muscle function, Exercise performance, Skeletal muscle, Doping, Anti-Doping, Enantiomeric analysis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects receive placebo treatment
Arm Title
Long acting beta2-agonist
Arm Type
Experimental
Arm Description
Subjects are treated with long-acting beta2-agonist formoterol
Arm Title
Short acting beta2-agonist
Arm Type
Experimental
Arm Description
Subjects are treated with short-acting beta2-agonist terbutaline
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Subjects are treated with daily inhalation of formoterol
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Intervention Description
Subjects are treated with daily inhalation of terbutaline
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects are treated with placebo
Primary Outcome Measure Information:
Title
Proteome enrichment
Description
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Change in body composition (measured by dual energy x ray absorptiometry)
Time Frame
Baseline, 2 weeks, 4 weeks and 6 weeks
Title
Maximal oxygen consumption (VO2max)
Description
Change in VO2max (measured during bike ergometer cycling to exhaustion)
Time Frame
Baseline, 2 weeks, 4 weeks and 6 weeks
Other Pre-specified Outcome Measures:
Title
Drug exposure
Description
Measured in urine using enantiomeric analysis
Time Frame
Day 1-14 and day 49-56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
August Krogh Building
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Hostrup, PhD
Phone
+4524474785
Email
mhostrup@nexs.ku.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Beta2-adrenergic Agonism and Muscle Remodelling
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