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

NCT ID: NCT03775902

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Healthy subjects

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo tablet

Nicorandil

Intervention Type DRUG

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

Insulin resistant

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo tablet

Nicorandil

Intervention Type DRUG

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

Interventions

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Placebo

placebo tablet

Intervention Type DRUG

Nicorandil

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Copenhagen

Copenhagen, Danmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NAK-KATP

Identifier Type: -

Identifier Source: org_study_id

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