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

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Nicorandil
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring skeletal muscle, muscle fatigue, ion handling

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy subjects

Insulin resistant

Arm Description

Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.

Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.

Outcomes

Primary Outcome Measures

Extracellular potassium concentration meassured with microdialysis
Interstitial potassium

Secondary Outcome Measures

Performance (time to exhaustion) during knee extensor exercise
Muscle exercise tolerance

Full Information

First Posted
December 4, 2018
Last Updated
July 4, 2023
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03775902
Brief Title
Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development
Official Title
Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 insulin resistant subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
skeletal muscle, muscle fatigue, ion handling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
Arm Title
Insulin resistant
Arm Type
Experimental
Arm Description
Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)
Primary Outcome Measure Information:
Title
Extracellular potassium concentration meassured with microdialysis
Description
Interstitial potassium
Time Frame
Changes in potassium handling from the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks
Secondary Outcome Measure Information:
Title
Performance (time to exhaustion) during knee extensor exercise
Description
Muscle exercise tolerance
Time Frame
Changes in performance during the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non smokers HbA1c <38 mmol/mol (<5.7%), HOMA-IR > 1.7 (insulin resistant) VO2max <40 ml/kg/min (insulin resistant), 45-55 ml/kg/m2 (healthy) BMI >26 kg/m2 (insulin resistant), 19-26 kg/m2 (healthy) Exclusion Criteria: Use of antidiabetic medication or any other medication deemed to interfere with study outcomes Allergy towards Nicorandil Chronic disease other than type 2 diabetes deemed to interfere with study outcomes Excessive alcohol consumption (>14 units/week) Abnormal ECG
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
State/Province
Danmark
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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

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