Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy (NCT07480330) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy
80 participantsStarted 2026-03-25
Plain-language 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).
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum Neurofilament Light Chain Levels
Timeframe: At baseline
2
Balance Performance
Timeframe: Baseline
3
Fear of Falling
Timeframe: Baseline
Trial details
NCT IDNCT07480330
SponsorKanuni Sultan Suleyman Training and Research Hospital