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Beta2-mimetic and Central Nervous System (BETACTIV)

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ClinicalTrials.gov Identifier: NCT02925130
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adrenergic Beta-2 Agonist Effect Albuterol Effect Drug: Salbutamol Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation
Study Start Date : October 2016
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : September 28, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Albuterol

Placebo Comparator: Placebo
Acute oral intake of a placebo
Drug: Placebo
Acute oral intake of a placebo drug
Other Name: Albuterol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Exercise endurance [ Time Frame: Measured immediatly after treatment intake (within 1 h) ]
    Time to exhaustion during the exercise muscle test.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925130


Locations
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France
Grenoble University Hospital
Grenoble, France, 38042
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Michel Guinot, MD PhD University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02925130     History of Changes
Other Study ID Numbers: 38RC14339
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action