Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775902
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Morten Hostrup, PhD, University of Copenhagen

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 pre/diabetic subjects.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo, Nicorandil, Glimepiride Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Potassium
Drug Information available for: Glimepiride

Arm Intervention/treatment
Experimental: Healthy subjects
Three experimental day where the effect of Nicorandil (20mg), Glibenclamide (3,5mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
Drug: Placebo, Nicorandil, Glimepiride
On three separate experimental days, one of the two drugs or placebo is administered in tablet form.

Experimental: Pre and/or type 2 diabetics
Three experimental day where the effect of Nicorandil (20mg), Glibenclamide (3,5mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
Drug: Placebo, Nicorandil, Glimepiride
On three separate experimental days, one of the two drugs or placebo is administered in tablet form.




Primary Outcome Measures :
  1. Extracellular potassium concentration meassured with microdialysis [ Time Frame: Changes in potassium handling from the placebo experimental day compared to the experimental days with Nicorandil or Glibenclamide ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks ]

Secondary Outcome Measures :
  1. 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 or Glibenclamide ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non smokers
  • HbA1c <38mmol/mol and >42 mmol/mol
  • VO2max <40 ml/kg/min
  • BMI >26 kg/m2

Exclusion Criteria:

  • Use of antidiabetic medication
  • Allergy towards Nicorandil of Glimepiride
  • Chronic disease other than type 2 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775902


Locations
Layout table for location information
Denmark
University of Copenhagen
Copenhagen, Danmark, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Layout table for additonal information
Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03775902    
Other Study ID Numbers: NAK-KATP
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Fatigue
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nicorandil
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances