[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481218":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":63,"centralContacts":71,"locations":80,"responsibleParty":97,"collaborators":100,"id":105,"slug":10,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":10,"studyType":118,"phases":10,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Type 1 diabetes without known peripheral neuropathy",null,"People with type 1 diabetes without known peripheral neuropathy with \"limited\" diabetes duration",[13,14,15,16,17,18,19],"Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density","Diagnostic Test: Perception Threshold Tracking","Diagnostic Test: Thermal perception thresholds","Diagnostic Test: Corneal confocal Microscopy","Diagnostic Test: MRI","Diagnostic Test: Nerve conduction studies","Other: Composite scores and questionnaires",[21,28,34,40,46,52,58],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Skin biopsies with quantification of intra-epidermal nerve fibre density","Skin biopsy",[9],[27],"PGP9.5, antibodies for subsets of ion-channels ect",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Perception Threshold Tracking","Transcutaneous stimulation of large and small nerve fibres using weak electrical currents",[9],[33],"PTT",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Thermal perception thresholds","Heat and cold perception thresholds",[9],[39],"Quantitative Sensory Testing",{"type":22,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Corneal confocal Microscopy","Corneal nerve fibre density, corneal nerve fibre length, corneal nerve branch density",[9],[45],"CCM",{"type":22,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"MRI","Functional and structural MRI pictures of peripheral nerves and CNS",[9],[51],"fMRI, DTI, neurography",{"type":22,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Nerve conduction studies","Nerve conduction and amplitude of Sural nerve",[9],[57],"NC-STAT DPNCheck",{"type":6,"name":59,"description":59,"armGroupLabels":60,"otherNames":61},"Composite scores and questionnaires",[9],[62],"DN4, MNSI, NDS, NAFF",[64,68],{"name":65,"affiliation":66,"role":67},"Peter Vestergaard, PhD","Steno Diabetes Center North Denmark","STUDY_CHAIR",{"name":69,"affiliation":66,"role":70},"Johan M Røikjer, PhD","PRINCIPAL_INVESTIGATOR",[72,76],{"name":69,"role":73,"phone":74,"phoneExt":10,"email":75},"CONTACT","+45 97663651","j.roeikjaer@rn.dk",{"name":77,"role":73,"phone":78,"phoneExt":10,"email":79},"Niels Ejskjaer, PhD","+45 +4597663656","n.ejskjaer@rn.dk",[81],{"facility":5,"status":82,"city":83,"state":10,"zip":84,"country":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"RECRUITING","Aalborg","9000","Denmark",{"type":87,"coordinates":88},"Point",[89,90],9.9187,57.048,{"lat":90,"lon":89},[93],{"name":94,"role":73,"phone":95,"phoneExt":96,"email":10},"Johan Røikjer, MD, PhD","97666092","+45",{"type":70,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Johan Bovbjerg Røikjer","Primary Investigator",[101,103],{"name":102,"class":6},"Aalborg University",{"name":104,"class":6},"University of Aarhus","100481218",false,"NCT05546138","Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy","Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy (NeuroPredict)","NeuroPredict","Inclusion Criteria:\n\n* Men and women aged 18-80 years\n* Diagnosed with diabetes (of any type)\n* No clinically established diabetic peripheral neuropathy at inclusion\n\nExclusion Criteria:\n\n* Alcohol or drug abuse within the last year (prior to inclusion)\n* Chemotherapy (prior or within study period) or experimental medicine\n* Severe vitamin deficiencies\n* Inability to understand or comply with the examinations\n* Planned or likely discontinuation of care at Aalborg University Hospital\n* Known hematologic disorders resulting in a markedly reduced ability to stop small bleedings\n* Severe limb ischemia\n* Active diabetic foot ulcers\n* Previous amputations\n* Severe skin diseases or diseases known to cause neural damage\n* Pregnancy at inclusion","ALL","18 Years","60 Years",{"count":116,"type":117},200,"ESTIMATED","OBSERVATIONAL","Predicting early onset neuropathy in people with type 1 diabetes",[121,122,123],"Neuropathy, Diabetic","Small Nerve Fiber Neuropathy","Type 1 Diabetes",[125],"Diabetic neuropathy, Early detection, Clinical Endpoints, Prediction, Risk stratification","2024-06-27",{"date":128,"type":129},"2024-06-28","ACTUAL",{"date":131,"type":129},"2023-10-01",{"date":133,"type":117},"2029-12-31",{"name":5,"class":6},1]