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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775902
• Other study ID #: NAK-KATP
• Status: Completed
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Insulin Resistance

Intervention

Drug:
• Placebo
placebo tablet
• Nicorandil
20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracellular potassium concentration meassured with microdialysis	Interstitial potassium	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	Performance (time to exhaustion) during knee extensor exercise	Muscle exercise tolerance	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.