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Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

Primary Purpose

High Altitude Effects

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Acetazolamide 250Mg Tab
Methazolamide Pill
Placebo
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for High Altitude Effects focused on measuring exercise

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of WaterlooRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Methazolamide

Acetazolamide

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Time to complete a 5 km time trial after each experimental day (Days 3-5)
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

Expired Minute Ventilation
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
Oxyhemoglobin saturation
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

Full Information

First Posted
September 8, 2022
Last Updated
September 21, 2023
Sponsor
University of Waterloo
Collaborators
Wilderness Medical Society
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1. Study Identification

Unique Protocol Identification Number
NCT05575180
Brief Title
Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
Official Title
Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Wilderness Medical Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Effects
Keywords
exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methazolamide
Arm Type
Experimental
Arm Description
Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral
Intervention Type
Drug
Intervention Name(s)
Acetazolamide 250Mg Tab
Intervention Description
Oral acetazolamide
Intervention Type
Drug
Intervention Name(s)
Methazolamide Pill
Intervention Description
Oral Methazolamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo
Primary Outcome Measure Information:
Title
Time to complete a 5 km time trial after each experimental day (Days 3-5)
Description
Primary endpoint is the time to complete a 5 km exercise task in the three arms of the trial (acetazolamide, methazolamide, placebo)
Time Frame
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
Secondary Outcome Measure Information:
Title
Expired Minute Ventilation
Description
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
Time Frame
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
Title
Oxyhemoglobin saturation
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Cardiovascular - e.g., hypertension Metabolic - e.g., type 1 or 2 diabetes Respiratory - e.g., chronic obstructive pulmonary disease, asthma Digestive - e.g., ulcerative colitis Arthritis 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Dominelli, PhD
Phone
519-888-4567
Ext
46699
Email
paolo.dominelli@uwaterloo.ca
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Dominelli, PhD
Phone
5198884567
Ext
46699
Email
paolo.dominelli@uwaterloo.ca

12. IPD Sharing Statement

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Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

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