Insulin ResistanceNCT03775902
Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development
A study testing Nicorandil in people with Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Nicorandil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Dec 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects
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.
- Conditions
- Insulin Resistance
- Being tested
- Placebo, Nicorandil
- Keywords
- skeletal muscle, muscle fatigue, ion handling
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo tablet
NicorandilDrug
20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo; Drug: Nicorandil |
| 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. Receives: Drug: Placebo; Drug: Nicorandil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular potassium concentration meassured with microdialysis
Interstitial potassium
Measured: 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
Muscle exercise tolerance
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start19 Dec 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775902
- Sponsor's protocol ID
- NAK-KATP
- Status last verified
- Jul 2023
- First submitted
- 4 Dec 2018
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects
- ClinicalTrials.gov ID
- NCT03775902
- Acronym / sponsor ID
- NAK-KATP
- Conditions
- Insulin Resistance
- Keywords
- skeletal muscle, muscle fatigue, ion handling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Drug: Placebo, Drug: NicorandilTwo 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 | Experimental | Drug: Placebo, Drug: NicorandilTwo 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplacebo tablet | Drug | Healthy subjects, Insulin resistant |
| Nicorandil20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC) | Drug | Healthy subjects, Insulin resistant |
Primary outcome
Extracellular potassium concentration meassured with microdialysis
Time frame: 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
1 secondary outcome
Performance (time to exhaustion) during knee extensor exercise
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicorandil in people with Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular potassium concentration meassured with microdialysis (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.