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Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy

NCT07480330 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

The 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).

Conditions

  • Diabetic Polyneuropathy

Interventions

OTHER

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.

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Principal Investigators

  • Zeynep Karakuzu Güngör, M.D · Kanuni Sultan Süleyman Training and Research Hospital

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2026-04-30
Completion
2026-05-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07480330 on ClinicalTrials.gov