Beta2-adrenergic Agonism and Muscle Remodelling

March 24, 2020 updated by: Morten Hostrup, PhD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • August Krogh Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug exposure
Time Frame: Day 1-14 and day 49-56
Measured in urine using enantiomeric analysis
Day 1-14 and day 49-56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Hostrup, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2018

Primary Completion (ANTICIPATED)

May 30, 2021

Study Completion (ANTICIPATED)

May 30, 2021

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (ACTUAL)

June 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOR/TER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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