Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT03775902
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020108', 'term': 'Nicorandil'}], 'ancestors': [{'id': 'D009566', 'term': 'Nitrates'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extracellular potassium concentration meassured with microdialysis', 'timeFrame': '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', 'description': 'Interstitial potassium'}], 'secondaryOutcomes': [{'measure': 'Performance (time to exhaustion) during knee extensor exercise', 'timeFrame': '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.', 'description': 'Muscle exercise tolerance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skeletal muscle', 'muscle fatigue', 'ion handling'], 'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non smokers\n* HbA1c \\<38 mmol/mol (\\<5.7%), HOMA-IR \\> 1.7 (insulin resistant)\n* VO2max \\<40 ml/kg/min (insulin resistant), 45-55 ml/kg/m2 (healthy)\n* BMI \\>26 kg/m2 (insulin resistant), 19-26 kg/m2 (healthy)\n\nExclusion Criteria:\n\n* Use of antidiabetic medication or any other medication deemed to interfere with study outcomes\n* Allergy towards Nicorandil\n* Chronic disease other than type 2 diabetes deemed to interfere with study outcomes\n* Excessive alcohol consumption (\\>14 units/week)\n* Abnormal ECG'}, 'identificationModule': {'nctId': 'NCT03775902', 'briefTitle': 'Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects', 'orgStudyIdInfo': {'id': 'NAK-KATP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': '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.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicorandil']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin resistant', 'description': '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.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicorandil']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo tablet', 'armGroupLabels': ['Healthy subjects', 'Insulin resistant']}, {'name': 'Nicorandil', 'type': 'DRUG', 'description': '20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)', 'armGroupLabels': ['Healthy subjects', 'Insulin resistant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Danmark', 'country': 'Denmark', 'facility': 'University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}