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临床试验/NCT03775902
NCT03775902已完成不适用

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

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年12月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Extracellular potassium concentration meassured with microdialysis

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Healthy subjects

Experimental

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.

干预措施: Placebo (Drug)

Healthy subjects

Experimental

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.

干预措施: Nicorandil (Drug)

Insulin resistant

Experimental

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.

干预措施: Placebo (Drug)

Insulin resistant

Experimental

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.

干预措施: Nicorandil (Drug)

结局指标

主要结局

Extracellular potassium concentration meassured with microdialysis

时间窗: 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

次要结局

  • Performance (time to exhaustion) during knee extensor exercise(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Morten Hostrup, PhD

Associate Professor

University of Copenhagen

研究点 (1)

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