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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03775902
Enrollment
16
Registered
2018-12-14
Start date
2018-12-19
Completion date
2020-01-01
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

skeletal muscle, muscle fatigue, ion handling

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.

Interventions

DRUGPlacebo

placebo tablet

DRUGNicorandil

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

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Extracellular potassium concentration meassured with microdialysisChanges 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 weeksInterstitial potassium

Secondary

MeasureTime frameDescription
Performance (time to exhaustion) during knee extensor exerciseChanges 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026