- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758470
Muscle Fatigue and Carbonic Anhydrase Inhibitors
September 21, 2018 updated by: Glen Foster, University of British Columbia
The Effect of Carbonic Anhydrase Inhibitors on the Pulmonary System Response to Muscle Fatigue.
The objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development.
A fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age: 18-40 years.
- Regularly physically active
- Male
Exclusion Criteria:
- current or ex-smokers
- pulmonary function <80% of predicted
- esophageal tumour or ulcer
- have had recent (<6 months) musculoskeletal injury or any surgery to the lower leg
- have contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
- are obese (BMI >30 Kg/m2)
- taking diuretics, blood thinners, or anti-platelet drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Acetazolamide
Participants will be dosed 250mg acetazolamide (p.o.) three times per day for two days prior to and a single dose on the morning of the experimental day.
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250 mg, taken orally three times per day
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EXPERIMENTAL: Methazolamide
Participants will be dosed 100mg Methazolamide (p.o.) two times per day separated by a placebo dose for two days prior to and a single dose on the morning of the experimental day.
The placebo dose is used to match the timing and number of pills taken between all arms of the study.
|
100mg, taken orally two times per day.
A placebo pill will be taken between each dose of methazolamide to match the timing of doses and the number of pills between study arms.
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PLACEBO_COMPARATOR: Placebo
Participants will take three placebo pills per day for two days prior to and a single dose on the morning of the experimental day.
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A placebo will be taken three times per day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in trans-diaphragmatic pressure generation to supramaximal phrenic nerve stimulation following inspiratory threshold loading.
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
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Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
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Change in plantar flexor muscle group torque generation to supramaximal tibial nerve stimulation following an isometric loading protocol
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
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Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal inspiratory pressure maneuvers
Time Frame: Baseline and immediately following loading protocol
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Baseline and immediately following loading protocol
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Maximal Voluntary Contraction of the Plantar Flexor Muscle Group
Time Frame: Baseline and immediately following the loading protocol
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Baseline and immediately following the loading protocol
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Contraction time and half-relaxation time
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Esophageal and Gastric Pressure
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Heart Rate
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Beat-by-beat blood pressure
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (ACTUAL)
June 30, 2017
Study Completion (ACTUAL)
June 30, 2017
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 28, 2016
First Posted (ESTIMATE)
May 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2018
Last Update Submitted That Met QC Criteria
September 21, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-00896
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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