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

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

    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • University of British Columbia

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.
250 mg, taken orally three times per day
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.
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.
A placebo will be taken three times per day

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
Baseline, 1, 5, 10, 20, and 30 minutes following the loading protocol for each arm of the study
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
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
Baseline and immediately following loading protocol
Maximal Voluntary Contraction of the Plantar Flexor Muscle Group
Time Frame: Baseline and immediately following the loading protocol
Baseline and immediately following the loading protocol
Contraction time and half-relaxation time
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

Other Outcome Measures

Outcome Measure
Time Frame
Esophageal and Gastric Pressure
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Heart Rate
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Beat-by-beat blood pressure
Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol
Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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