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NCT07480330

Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy

Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

View on ClinicalTrials.gov

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).

Official title: Association Between Serum Neurofilament Light Chain (NfL) Levels and Neuropathy Severity, Balance Performance, and Fall Risk in Diabetic Polyneuropathy

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-03-25

Completion Date

2026-05-15

Last Updated

2026-03-18

Healthy Volunteers

No

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.