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Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development

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ClinicalTrials.gov Identifier: NCT03775902
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Morten Hostrup, PhD, University of Copenhagen

Study Description
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Brief Summary:
To investigate the role of ATP sensitive K+ potassium channels and the Na+/K+ pump in the development of fatigue in healthy and in pre/diabetic subjects.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo, Nicorandil, Glimepiride Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Potassium
Drug Information available for: Glimepiride

Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy subjects
Three experimental day where the effect of Nicorandil (20mg), Glibenclamide (3,5mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
 Drug: Placebo, Nicorandil, Glimepiride
On three separate experimental days, one of the two drugs or placebo is administered in tablet form.
Experimental: Pre and/or type 2 diabetics
Three experimental day where the effect of Nicorandil (20mg), Glibenclamide (3,5mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
 Drug: Placebo, Nicorandil, Glimepiride
On three separate experimental days, one of the two drugs or placebo is administered in tablet form.


Outcome Measures
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Primary Outcome Measures :
  1. Extracellular potassium concentration meassured with microdialysis [ Time Frame: Changes in potassium handling from the placebo experimental day compared to the experimental days with Nicorandil or Glibenclamide ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks ]

Secondary Outcome Measures :
  1. Performance (time to exhaustion) during knee extensor exercise [ Time Frame: Changes in performance during the placebo experimental day compared to the experimental days with Nicorandil or Glibenclamide ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non smokers
  • HbA1c <38mmol/mol and >42 mmol/mol
  • VO2max <40 ml/kg/min
  • BMI >26 kg/m2

Exclusion Criteria:

  • Use of antidiabetic medication
  • Allergy towards Nicorandil of Glimepiride
  • Chronic disease other than type 2 diabetes
Contacts and Locations
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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): NCT03775902


Locations
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Denmark
University of Copenhagen
Copenhagen, Danmark, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
More Information
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Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03775902    
Other Study ID Numbers: NAK-KATP
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Fatigue
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nicorandil
Glimepiride
Anti-Arrhythmia Agents
 Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients