Beta2-adrenergic Agonism and Muscle Remodelling

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2021

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Subjects receive placebo treatment
  • Experimental: Long acting beta2-agonist
    • Subjects are treated with long-acting beta2-agonist formoterol
  • Experimental: Short acting beta2-agonist
    • Subjects are treated with short-acting beta2-agonist terbutaline

Clinical Trial Outcome Measures

Primary Measures

  • Proteome enrichment
    • Time Frame: Baseline and 6 weeks
    • Change in enrichment (measured in muscle biopsies and assessed using GO annotations)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Morten Hostrup, PhD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Morten Hostrup, PhD, Associate Professor – University of Copenhagen

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