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Completed

NCT Number: NCT03775902

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

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Danmark, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

placebo tablet

nicorandil

Drug

20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)

Primary outcomes

  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 ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks

    Interstitial potassium

Secondary outcomes

  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 ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks.

    Muscle exercise tolerance

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2018
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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