Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedStudy Start
First participant enrolled
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 6, 2023
July 1, 2023
1 year
December 4, 2018
July 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
Healthy subjects
EXPERIMENTALTwo 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.
Insulin resistant
EXPERIMENTALTwo 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.
Interventions
20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Copenhagen
Copenhagen, Danmark, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 14, 2018
Study Start
December 19, 2018
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
July 6, 2023
Record last verified: 2023-07