Clinical trial

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

Name

NAK-KATP

Description

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.

Trial arms

Trial start

2018-12-19

Estimated PCD

2020-01-01

Trial end

2020-01-01

Status

Completed

Treatment

Placebo

placebo tablet

Arms:

Healthy subjects, Insulin resistant

Nicorandil

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

Arms:

Healthy subjects, Insulin resistant

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2023-07-06

1 organization

1 product

1 drug

1 indication

Organization

University of Copenhagen

Drug

Varlilumab

Indication

Insulin Resistance

Product

Nicorandil