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Muscle Fatigue and Carbonic Anhydrase Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02758470
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Glen Foster, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Hypoxia Drug: Acetazolamide Drug: Methazolamide Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Carbonic Anhydrase Inhibitors on the Pulmonary System Response to Muscle Fatigue.
Study Start Date : November 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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.
Drug: Acetazolamide
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.
Drug: Methazolamide
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.
Other: Placebo
A placebo will be taken three times per day




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Maximal inspiratory pressure maneuvers [ Time Frame: Baseline and immediately following loading protocol ]
  2. Maximal Voluntary Contraction of the Plantar Flexor Muscle Group [ Time Frame: Baseline and immediately following the loading protocol ]
  3. Contraction time and half-relaxation time [ Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol ]

Other Outcome Measures:
  1. Esophageal and Gastric Pressure [ Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol ]
  2. Heart Rate [ Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol ]
  3. Beat-by-beat blood pressure [ Time Frame: Baseline, 1, 5, 10, 20, and 30 minutes post loading protocol ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758470


Locations
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Canada, British Columbia
University of British Columbia
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Glen E Foster, Ph.D. University of British Columbia
Publications of Results:
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Responsible Party: Glen Foster, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02758470    
Other Study ID Numbers: H16-00896
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Keywords provided by Glen Foster, University of British Columbia:
Muscle Fatigue
Acetazolamide
Methazolamide
Additional relevant MeSH terms:
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Fatigue
Hypoxia
Signs and Symptoms, Respiratory
Acetazolamide
Methazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs