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).
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Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, hypothyroidism, alcohol abuse, chemotherapy) Renal dysfunction (eGFR < 60 mL/min/1.73 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
Adults with type 2 diabetes mellitus aged 30-75 years attending a Physical Medicine and Rehabilitation outpatient clinic, including patients with diabetic polyneuropathy and diabetic individuals without neuropathy serving as controls.
Case-control
Cross-sectional
Blood Sample Collection and Clinical Assessment
Other interventionParticipants 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.
Serum Neurofilament Light Chain Levels
To evaluate the association between serum Neurofilament Light Chain (NfL) levels and the presence and severity of diabetic polyneuropathy assessed by the Michigan Neuropathy Screening Instrument (MNSI) and electrophysiological findings.
Balance Performance
To evaluate the relationship between serum Neurofilament Light Chain (NfL) levels and balance performance measured using the Berg Balance Scale in patients with diabetic polyneuropathy.
Fear of Falling
To assess the association between serum Neurofilament Light Chain (NfL) levels and fear of falling using the Falls Efficacy Scale-International (FES-I).
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