Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy
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Conditions studied: Diabetic Polyneuropathy
In brief
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).
Key facts
- Study ID
- NCT07480330
- Run by
- Kanuni Sultan Suleyman Training and Research Hospital
- People needed
- 80
- Starts
- 2026-03-25
- Expected to finish
- 2026-05-15
- Last updated by the study team
- 2026-03-18
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion 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
- For the DPN+ group:
- Presence of diabetic polyneuropathy confirmed by clinical examination, Michigan Neuropathy Screening Instrument (MNSI), and nerve conduction studies
- For the DPN- group:
- Type 2 diabetes mellitus without clinical or electrophysiological evidence of diabetic polyneuropathy
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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