Beta2-adrenergic Agonism and Muscle Remodelling

Not Applicable

• Conditions: Hypertrophy; Physiologic Hypertrophy; Physical Activity
• Interventions: Drug: Terbutaline; Other: Placebo; Drug: Formoterol

• Registration Number: NCT03565302
• Lead Sponsor: Morten Hostrup, PhD

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2018-06-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short acting beta2-agonist	Terbutaline	Subjects are treated with short-acting beta2-agonist terbutaline
Control	Placebo	Subjects receive placebo treatment
Long acting beta2-agonist	Formoterol	Subjects are treated with long-acting beta2-agonist formoterol

Primary Outcome Measures

Name	Time	Method
Proteome enrichment	Baseline and 6 weeks	Change in enrichment (measured in muscle biopsies and assessed using GO annotations)

Secondary Outcome Measures

Name	Time	Method
Body composition	Baseline, 2 weeks, 4 weeks and 6 weeks	Change in body composition (measured by dual energy x ray absorptiometry)
Maximal oxygen consumption (VO2max)	Baseline, 2 weeks, 4 weeks and 6 weeks	Change in VO2max (measured during bike ergometer cycling to exhaustion)

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark