Beta2-mimetic and Central Nervous System

NCT02925130 | Completed

• 1 other identifier: 38RC14339
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenergic Beta-2 Agonist Effect; Albuterol Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cortical activation

  Measured immediatly after treatment intake (within 1 h)

• Exercise endurance

  Measured immediatly after treatment intake (within 1 h)

Study Arms (3)

Inhaled Salbutamol

EXPERIMENTAL

Acute inhalation of 800 microgram Salbutamol

Drug: Salbutamol

Oral Salbutamol

EXPERIMENTAL

Acute oral intake of 4 mg Salbutamol

Drug: Salbutamol

Placebo

PLACEBO COMPARATOR

Acute oral intake of a placebo

Drug: Placebo

Interventions

Salbutamol DRUG

Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.

Also known as: Albuterol

Inhaled Salbutamol; Oral Salbutamol

Placebo DRUG

Acute oral intake of a placebo drug

Also known as: Albuterol

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, 38042, France

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Michel Guinot, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: October 1, 2016
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)