Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT03513835
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017240', 'term': 'Mitochondrial Myopathies'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lactate / pyruvate ratio', 'timeFrame': '1 hour', 'description': 'Changes between: before, during and after submaximal exercise'}, {'measure': 'Serum Acyl-carnitine levels', 'timeFrame': '1 hour', 'description': 'Changes between: before and after exercise, fasted and fed.'}, {'measure': 'Serum GDF-15', 'timeFrame': '1 hour', 'description': 'Changes between: before and after exercise, fasted and fed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitochondrial Myopathies', 'Healthy Controls']}, 'referencesModule': {'references': [{'pmid': '34273558', 'type': 'DERIVED', 'citation': 'Lokken N, Skriver SV, Khawajazada T, Storgaard JH, Vissing J. Plasma lactate responses during and after submaximal handgrip exercise are not diagnostically helpful in mitochondrial myopathy. Mitochondrion. 2021 Sep;60:21-26. doi: 10.1016/j.mito.2021.07.002. Epub 2021 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Genetically verified primary Mitochondrial disorder with myopathy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-75\n* verified mitochondrial myopathy\n* or healthy control\n* or disease control (another neuromuscular disease)\n\nExclusion Criteria:\n\n* Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.\n* Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction\n* Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03513835', 'briefTitle': 'Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies', 'orgStudyIdInfo': {'id': 'H-17032512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mitochondrial myopathy', 'interventionNames': ['Diagnostic Test: Diagnostic screenings tests']}, {'label': 'Healthy controls', 'interventionNames': ['Diagnostic Test: Diagnostic screenings tests']}], 'interventions': [{'name': 'Diagnostic screenings tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.', 'armGroupLabels': ['Healthy controls', 'Mitochondrial myopathy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen Neuromuscular Center, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD-student', 'investigatorFullName': 'Nicoline Løkken', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}