Emergence of a Predictive Clinical Biomarker for Diabetic Neuropathy
- From the Department of Medicine, Prince of Wales Clinical School, University of New South Wales, Sydney, Australia, and Neuroscience Research Australia, Sydney, Australia
- Corresponding author: Matthew C. Kiernan, .
Diabetes is often complicated by the development of neuropathy, with up to a third of the direct costs of diabetes attributed to neuropathy-related morbidity (1). The incidence of diabetic neuropathy increases with duration of diabetes, affecting up to 50% of diabetic patients after 25 years of disease (2). To date, the development of neuroprotective and disease-modifying approaches for diabetic neuropathy has been disappointing. Therapeutic approaches with aldose reductase inhibitors and nerve growth factors have so far proved unsuccessful (3). Despite the promise of positive outcomes in research animal models, clinical trials of neuroprotective therapies have failed to yield significant benefit. In part, this lack of success reflects the absence of sensitive and robust methods for early detection of neuropathy (4). It is perhaps not surprising that initiation of therapy when axonal degeneration is advanced—well after the horse has left the gate—has resulted in trials that have been negative to date.
When considering the design of large-scale clinical trials for diabetic neuropathy in the future, development of biomarkers that facilitate both early detection and monitoring of disease progression …