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Muscle Fatigue and Carbonic Anhydrase Inhibitors

Primary Purpose

Hypoxia

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Acetazolamide

Methazolamide

Placebo

About this trial

This is an interventional basic science trial for Hypoxia focused on measuring Muscle Fatigue, Acetazolamide, Methazolamide

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Methazolamide

Placebo

Arm Description

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.

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.

Participants will take three placebo pills per day for two days prior to and a single dose on the morning of the experimental day.

Outcomes

Primary Outcome Measures

Change in trans-diaphragmatic pressure generation to supramaximal phrenic nerve stimulation following inspiratory threshold loading.

Change in plantar flexor muscle group torque generation to supramaximal tibial nerve stimulation following an isometric loading protocol

Secondary Outcome Measures

Maximal inspiratory pressure maneuvers

Maximal Voluntary Contraction of the Plantar Flexor Muscle Group

Contraction time and half-relaxation time

Full Information

NCT ID

NCT02758470

First Posted

April 20, 2016

Last Updated

September 21, 2018

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02758470

Brief Title

Muscle Fatigue and Carbonic Anhydrase Inhibitors

Official Title

The Effect of Carbonic Anhydrase Inhibitors on the Pulmonary System Response to Muscle Fatigue.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia

Keywords

Muscle Fatigue, Acetazolamide, Methazolamide

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acetazolamide

Arm Type

Experimental

Arm Description

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.

Arm Title

Methazolamide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will take three placebo pills per day for two days prior to and a single dose on the morning of the experimental day.

Intervention Type

Drug

Intervention Name(s)

Acetazolamide

Intervention Description

250 mg, taken orally three times per day

Intervention Type

Drug

Intervention Name(s)

Methazolamide

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

A placebo will be taken three times per day

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Maximal inspiratory pressure maneuvers

Time Frame

Baseline and immediately following loading protocol

Title

Maximal Voluntary Contraction of the Plantar Flexor Muscle Group

Time Frame

Baseline and immediately following the loading protocol

Title

Contraction time and half-relaxation time

Time Frame

Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

Other Pre-specified Outcome Measures:

Title

Esophageal and Gastric Pressure

Time Frame

Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

Title

Heart Rate

Time Frame

Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

Title

Beat-by-beat blood pressure

Time Frame

Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glen E Foster, Ph.D.

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1V 1V7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

29792554

Citation

Dominelli PB, McNeil CJ, Vermeulen TD, Stuckless TJR, Brown CV, Dominelli GS, Swenson ER, Teppema LJ, Foster GE. Effect of acetazolamide and methazolamide on diaphragm and dorsiflexor fatigue: a randomized controlled trial. J Appl Physiol (1985). 2018 Sep 1;125(3):770-779. doi: 10.1152/japplphysiol.00256.2018. Epub 2018 May 24.

Results Reference

result

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Muscle Fatigue and Carbonic Anhydrase Inhibitors

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