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Surrogate Markers of Small Fiber Damage in Human Diabetic Neuropathy.

Division of Cardiovascular Medicine, University of Manchester, Manchester Diabetes Centre and Manchester Royal Infirmary, Manchester, UK¹
Division of Regenerative Medicine, University of Manchester, UK²
Diabetes Research Unit, Royal Hallamshire Hospital, Sheffield, UK³
Department of Neurophysiology, Manchester Royal Infirmary, Manchester, UK⁴
Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia⁵

Correspondence: rayaz.a.malik{at}man.ac.uk

Objective: Surrogate markers of diabetic neuropathy are being actively sought to facilitate the diagnosis, measure the progression and assess benefits of therapeutic intervention in patients with diabetic neuropathy. We have quantified small nerve fiber pathology using the technique of intraepidermal nerve fiber (IENF) assessment and the novel in vivo technique of corneal confocal microscopy (CCM).

Research Design and Methods: 54 diabetic patients stratified for neuropathy, using neurological evaluation, neurophysiology and quantitative sensory testing (QST) and 15 control subjects were studied. They underwent a punch skin biopsy to quantify intraepidermal nerve fibers and corneal confocal microscopy to quantify corneal nerve fibers.

Results: Intraepidermal nerve fiber density (IENFD), branch density (IENFBD) and branch length (IENFBL) showed a progressive reduction with increasing neuropathic severity, which was significant in patients with mild, moderate and severe neuropathy. CCM also showed a progressive reduction in corneal nerve fiber density (CNFD) and branch density (CNFBD) but the latter was significantly reduced even in diabetic patients without neuropathy. Both IENFD and CNFD correlated significantly with cold detection and heat as pain thresholds. Intraepidermal and corneal nerve fiber length was reduced in patients with painful compared to painless diabetic neuropathy.

Conclusions: Both IENF and CCM assessment accurately quantify small nerve fiber damage in diabetic patients. However, CCM quantifies small fiber damage rapidly and non-invasively and detects earlier stages of nerve damage compared to IENF pathology. This may make it an ideal technique to accurately diagnose and assess progression of human diabetic neuropathy.

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