Beta2-mimetic and Central Nervous System

Adrenergic Beta-2 Agonist Effect Clinical Trial

— BETACTIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925130
• Other study ID #: 38RC14339
• Status: Completed
• Phase: N/A
• First received: October 3, 2016
• Last updated: September 29, 2017
• Start date: October 2016
• Est. completion date: September 28, 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenergic Beta-2 Agonist Effect
• Albuterol Effect

Intervention

Drug:
• Salbutamol
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
• Placebo
Acute oral intake of a placebo drug

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal voluntary activation	Measurement performed by using transcranial magnetic stimulation, superimposed on submaximal and maximal quadricep contractions	Measured immediatly after treatment intake (within 1 h)
Secondary	Cortical activation	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)
Secondary	Exercise endurance	Time to exhaustion during the exercise muscle test.	Measured immediatly after treatment intake (within 1 h)