Beta2-mimetic and Central Nervous System (BETACTIV)

September 29, 2017 updated by: University Hospital, Grenoble

Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation

Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation and cerebral activation will be measured during motor tasks performed until exhaustion after acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.

Study Type

Interventional

Enrollment (Actual)

15

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

  • France
      • Grenoble, France, 38042
        • Grenoble University Hospital

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy subjects without respiratory and cordiovascular diseases
  • Male
  • Age between 18 and 35
  • Trained subjects (>6 hours of physical activity per week)
  • Non- or ex-smoker (smoking cessation since at least 1 year)

Exclusion Criteria:

  • Respiratory, cardiovascular and metabolic diseases
  • Neuromuscular diseases
  • thyrotoxicosis, or diabetes treated with insulin
  • alcoholism
  • MRI contraindication
  • TMS contraindication

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Salbutamol
Acute inhalation of 800 microgram Salbutamol
Drug: Salbutamol
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
Other Names:
  • Albuterol
Experimental: Oral Salbutamol
Acute oral intake of 4 mg Salbutamol
Drug: Salbutamol
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
Other Names:
  • Albuterol
Placebo Comparator: Placebo
Acute oral intake of a placebo
Drug: Placebo
Acute oral intake of a placebo drug
Other Names:
  • Albuterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal voluntary activation
Time Frame: Measured immediatly after treatment intake (within 1 h)
Measurement performed by using transcranial magnetic stimulation, superimposed on submaximal and maximal quadricep contractions
Measured immediatly after treatment intake (within 1 h)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical activation
Time Frame: Measured immediatly after treatment intake (within 1 h)
Measurement performed by using magnetic resonance imaging and the intensity of the BOLD signal in response to a motor task.
Measured immediatly after treatment intake (within 1 h)
Exercise endurance
Time Frame: Measured immediatly after treatment intake (within 1 h)
Time to exhaustion during the exercise muscle test.
Measured immediatly after treatment intake (within 1 h)

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Michel Guinot, MD PhD, University Hospital, Grenoble

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

October 1, 2016

Primary Completion (Actual)

September 28, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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