- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02925130
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
-
-
-
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
|
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
Other Names:
|
Experimental: Oral Salbutamol
Acute oral intake of 4 mg Salbutamol
|
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
Other Names:
|
Placebo Comparator: Placebo
Acute oral intake of a placebo
|
Acute oral intake of a placebo drug
Other Names:
|
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
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
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
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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