Beta2-adrenergic Agonism and Muscle Remodelling

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03565302
• Other study ID #: FOR/TER
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Physical Activity
• Physiologic Hypertrophy

Intervention

Drug:
• Formoterol
Subjects are treated with daily inhalation of formoterol
• Terbutaline
Subjects are treated with daily inhalation of terbutaline

Other:
• Placebo
Subjects are treated with placebo

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug exposure	Measured in urine using enantiomeric analysis	Day 1-14 and day 49-56
Primary	Proteome enrichment	Change in enrichment (measured in muscle biopsies and assessed using GO annotations)	Baseline and 6 weeks
Secondary	Body composition	Change in body composition (measured by dual energy x ray absorptiometry)	Baseline, 2 weeks, 4 weeks and 6 weeks
Secondary	Maximal oxygen consumption (VO2max)	Change in VO2max (measured during bike ergometer cycling to exhaustion)	Baseline, 2 weeks, 4 weeks and 6 weeks