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

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Drug: Placebo; Drug: Nicorandil

• Registration Number: NCT03775902
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Study Start: 2018-12-19
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Placebo	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.
Healthy subjects	Nicorandil	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.
Insulin resistant	Placebo	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.
Insulin resistant	Nicorandil	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.

Primary Outcome Measures

Name	Time	Method
Extracellular potassium concentration meassured with microdialysis	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	Interstitial potassium

Secondary Outcome Measures

Name	Time	Method
Performance (time to exhaustion) during knee extensor exercise	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.	Muscle exercise tolerance

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Copenhagen, Danmark, Denmark