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Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

Sponsor
University of Waterloo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05575180
Collaborator
Wilderness Medical Society (Other)
15
Enrollment
3
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetazolamide 250Mg Tab
  • Drug: Methazolamide Pill
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methazolamide

Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Drug: Methazolamide Pill
Oral Methazolamide
Active Comparator: Acetazolamide

Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Drug: Acetazolamide 250Mg Tab
Oral acetazolamide
Placebo Comparator: Placebo

Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Drug: Placebo
Oral placebo

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Expired Minute Ventilation [The 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

  2. Oxyhemoglobin saturation [The 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Waterloo
  • Wilderness Medical Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT05575180
Other Study ID Numbers:
  • 43720
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Waterloo
exercise
Additional relevant MeSH terms:
Altitude Sickness
Acetazolamide
Methazolamide

Study Results

No Results Posted as of Oct 12, 2022