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

University of Copenhagen

Status: Completed

Conditions: Insulin Resistance

Treatments: Drug: Placebo; Drug: Nicorandil

Study type: Interventional

Funder types: Other

Identifiers

NCT03775902

NAK-KATP

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Healthy subjects

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Nicorandil

Insulin resistant

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Nicorandil