MedPath

Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

Phase 4
Completed
Conditions
High Altitude Effects
Interventions
Registration Number
NCT05575180
Lead Sponsor
University of Waterloo
Brief Summary

A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Consent provided
  • Between ages of 18-40 years old
  • In good general health as evidences by medical history
  • Perform at least 150 mins of aerobic exercise per week, and engage in physical activity >2 days a week
  • Completed in an endurance event in the last 12 months
  • Ability to take oral medication, and be willing to adhere to the drug regimen
  • Be willing to have blood samples taken
Exclusion Criteria
  • Weigh 49kg or less, or are Obese (BMI >30 kg/m2)

  • Presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders:

    1. Cardiovascular - e.g., hypertension
    2. Metabolic - e.g., type 1 or 2 diabetes
    3. Respiratory - e.g., chronic obstructive pulmonary disease, asthma
    4. Digestive - e.g., ulcerative colitis
    5. Arthritis
    6. Cancer
  • Presence of any disorder or condition listed in the health screening questionnaire (see section 12.1)

  • Current use of Lonafarnib, Methenamine, Topamax, or steroids/corticosteroids

  • Known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or sulfonamides

  • Presence of bleeding or clotting disorders

  • Current smoker or cannabis user

  • Pregnant, suspect to be pregnant, currently planning a pregnancy, or nursing

  • Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
MethazolamideMethazolamide PillDrug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
AcetazolamideAcetazolamide 250Mg TabDrug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
PlaceboPlaceboDrug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
Primary Outcome Measures
NameTimeMethod
Time to complete a 5 km time trial after each experimental day (Days 3-5)The time to complete the 5 km time trial is measured after each time trial. The investigators will be blinded until all participants have completed each trial

Primary endpoint is the time to complete a 5 km exercise task in the three arms of the trial (acetazolamide, methazolamide, placebo)

Secondary Outcome Measures
NameTimeMethod
Oxyhemoglobin saturationThe average oxyhemoglobin saturation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial

The secondary endpoint oxyhemoglobin saturation will be measured using a pulse oximeter which measure the fraction of hemoglobin bound to oxygen. The value is expressed as a percent and measured continuously

Expired Minute VentilationThe average minute ventilation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial

The secondary endpoint expired minute ventilation will be measured using a flow meter (pneumotach) which measure flow and allows for the calculation of ventilation. The value is expressed in liters per min and measured continuously

Trial Locations

Locations (1)

University of Waterloo

🇨🇦

Waterloo, Ontario, Canada

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