[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629873":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":10,"responsibleParty":35,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":10,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"Kanuni Sultan Suleyman Training and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetic Polyneuropathy (DPN+)",null,"Participants with Type 2 diabetes mellitus diagnosed with diabetic polyneuropathy based on clinical examination, the Michigan Neuropathy Screening Instrument (MNSI), and electrophysiological evaluation using nerve conduction studies.",[13],"Other: Blood Sample Collection and Clinical Assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Diabetic Control (DPN-)","Participants with Type 2 diabetes mellitus without clinical or electrophysiological evidence of diabetic polyneuropathy who will serve as the control group.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Blood Sample Collection and Clinical Assessment","Participants will undergo venous blood sample collection for measurement of serum Neurofilament Light Chain (NfL) levels. Blood samples will be obtained after overnight fasting, centrifuged, and serum samples will be stored at -80°C until analysis. Serum NfL levels will be measured using a validated ELISA-based immunoassay. In addition, clinical assessments including the Michigan Neuropathy Screening Instrument (MNSI), Berg Balance Scale, and Falls Efficacy Scale-International (FES-I) will be performed to evaluate neuropathy severity, balance performance, and fall risk.",[15,9],[24],{"name":25,"affiliation":26,"role":27},"Zeynep Karakuzu Güngör, M.D","Kanuni Sultan Süleyman Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Zeynep Zeynep Karakuzu Güngör, M.D","CONTACT","Telephone: 905077750375","zeynepkarakuzu@hotmail.com.tr",{"name":25,"role":31,"phone":32,"phoneExt":10,"email":33},{"type":27,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Zeynep Karakuzu Güngör","Physical Medicine and Rehabilitation Specialist","100629873","serum-neurofilament-light-chain-levels-and-neuropathy-severity-in-diabetic-polyneuropathy-100629873",false,"NCT07480330","Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy","Association Between Serum Neurofilament Light Chain (NfL) Levels and Neuropathy Severity, Balance Performance, and Fall Risk in Diabetic Polyneuropathy","DPN-NFL","Inclusion Criteria:\n\nInclusion Criteria Age between 30 and 75 years Diagnosis of Type 2 Diabetes Mellitus for at least 1 year Ability to understand and complete clinical assessments and questionnaires Willingness to participate and provide written informed consent\n\nFor the DPN+ group:\n\nPresence of diabetic polyneuropathy confirmed by clinical examination, Michigan Neuropathy Screening Instrument (MNSI), and nerve conduction studies\n\nFor the DPN- group:\n\nType 2 diabetes mellitus without clinical or electrophysiological evidence of diabetic polyneuropathy\n\nExclusion Criteria:\n\n* Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, hypothyroidism, alcohol abuse, chemotherapy) Renal dysfunction (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²) Active infection or malignancy Inflammatory or autoimmune neurological diseases Central nervous system disorders (e.g., stroke, multiple sclerosis) Lumbar radiculopathy or peripheral entrapment neuropathy Severe visual impairment or balance disorders affecting testing Pregnancy Cognitive impairment preventing completion of questionnaires Patients with isolated small fiber neuropathy without electrophysiological evidence of large fiber involvement","ALL","30 Years","75 Years",{"count":50,"type":51},80,"ESTIMATED","OBSERVATIONAL","Diabetic polyneuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and is characterized by peripheral nerve damage caused by long-term hyperglycemia. Progressive sensory loss and impairment of proprioception may lead to balance disturbances, gait instability, and an increased risk of falls. Neurofilament Light Chain (NfL) has emerged as a potential biomarker of neuroaxonal injury in several neurological disorders.\n\nThe aim of this observational cross-sectional study is to investigate the relationship between serum Neurofilament Light Chain (NfL) levels and neuropathy severity, balance performance, and fall risk in patients with diabetic polyneuropathy. Neuropathy severity will be evaluated using the Michigan Neuropathy Screening Instrument (MNSI) and electrophysiological findings, while balance performance and fall risk will be assessed using the Berg Balance Scale and the Falls Efficacy Scale-International (FES-I).",[55],"Diabetic Polyneuropathy","NOT_YET_RECRUITING","2026-03-14",{"date":59,"type":60},"2026-03-18","ACTUAL",{"date":62,"type":51},"2026-03-25",{"date":64,"type":51},"2026-05-15",{"name":5,"class":6}]