Beta2-adrenergic Agonism and Muscle Remodelling

Sponsor

Morten Hostrup, PhD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03565302

Collaborator

(none)

Enrollment

Location

Arms

35.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypertrophy Physiologic Hypertrophy Physical Activity	Drug: Formoterol Drug: Terbutaline Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jun 25, 2018

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Subjects receive placebo treatment	Other: Placebo Subjects are treated with placebo
Experimental: Long acting beta2-agonist Subjects are treated with long-acting beta2-agonist formoterol	Drug: Formoterol Subjects are treated with daily inhalation of formoterol
Experimental: Short acting beta2-agonist Subjects are treated with short-acting beta2-agonist terbutaline	Drug: Terbutaline Subjects are treated with daily inhalation of terbutaline

Arm

Intervention/Treatment

Placebo Comparator: Control

Subjects receive placebo treatment

Other: Placebo

Subjects are treated with placebo

Experimental: Long acting beta2-agonist

Subjects are treated with long-acting beta2-agonist formoterol

Drug: Formoterol

Subjects are treated with daily inhalation of formoterol

Experimental: Short acting beta2-agonist

Subjects are treated with short-acting beta2-agonist terbutaline

Drug: Terbutaline

Subjects are treated with daily inhalation of terbutaline

Outcome Measures

Primary Outcome Measures

Proteome enrichment [Baseline and 6 weeks]
Change in enrichment (measured in muscle biopsies and assessed using GO annotations)

Secondary Outcome Measures

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)

Other Outcome Measures

Drug exposure [Day 1-14 and day 49-56]
Measured in urine using enantiomeric analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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