Early Detection and Combination Therapy for Diabetic Peripheral Neuropathy: What does the Future Look Like?

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Background

Peripheral neuropathy, the most prevalent chronic complication of diabetes, critically contributes to increased pain and risk of amputations, lower physical functioning and daily living burden, reduced quality of life, increased health care costs, and high mortality risk. Although intensive glucose control was shown to delay the onset and progression of diabetic peripheral neuropathy (DPN) in patients with type 1 diabetes, similar evidence is not available for the very vast majority of patients who have type 2 diabetes (T2D). In addition, despite continuous research, a disease modifying therapy to reverse human DPN is still not available. Thus, there is a critical knowledge gap in the development of DPN targeted therapies. Numerous pre-clinical studies have identified multiple causes for the development and progression of DPN. Targeting these different pathways in rodent models of DPN has provided hope of a potential treatment. However, subsequent studies in human subjects have been unsuccessful. There are many potential reasons that could explain this poor outcome including the lack of good clinical endpoints in human patients that provide for early detection of disease and misconception that a mono-therapeutic approach can be a successful treatment of a disease with multiple etiologies. The focus of the articles in this research topic will identify: a) what is known about imaging of the brain for early detection of painful DPN b) whether measuring changes in corneal nerve density could provide early detection of DPN, thereby identifying at risk subjects for early treatment, c) the future of combination therapy for treatment of pain in DPN, and d) from pre-clinical studies what is the most likely combination of agents that could provide a safe and efficacious treatment of the development and progression of DPN.

The goal of this research topic is to highlight the importance of early detection of DPN. How early detection could provide the best outcome for treatment of painful DPN as well as development of DPN. For clinical trials of DPN to be successful reliable endpoints at the earliest stage of the disease in needed. About 30% of subjects with DPN suffer from painful conditions that negatively impacts their daily living and quality of life. Current medications are far from successful in treating this condition and new approaches are needed to provide relief for these patients. An article in this research topic will examine the potential benefit of proper dose management and use of combinations of agents to achieve pain relief. We will re-visit pre-clinical studies of diabetic rodents to determine what combination therapies will have the potential for best outcome for DPN management. Finally, we will consider which end-points may enable us to successfully navigate the graveyard of clinical trials in DPN.

Professor Dinesh Selvarajah will provide an article detailing the advancements of brain imaging for the detection of painful DPN and potential of this important methodology as a tool for determining treatment outcome success objectively. The title of his review article; 'New Neurobiology of Painful Diabetic Neuropathy: Insights from Neuroimaging Studies'.

Professor Solomon Tesfaye will provide an article describing the current state of treatment of painful DPN and the potential benefit of combination therapy on this debilitating and demoralizing condition of DPN. The title of his review article; ‘Combination treatment for painful diabetic neuropathy’.

Professor Rayaz Malik will address why we currently have no FDA approved disease modifying therapies for DPN in relation to inadequate end-points in clinical trials. He will then focus on how corneal confocal microscopy could be used to detect early DPN and nerve regeneration in clinical trials of disease modifying treatments. The title of his review article is; ‘Clinical trials in diabetic neuropathy: A time to challenge the dogma’.

Dr. Mark Yorek will provide information from pre-clinical studies of the rationale and success of combination therapy in rodent models of DPN and which ones may provide the best chance of success in human subjects. The title of his article; ‘Combination Therapy is it the Future for Successfully Treating Peripheral Diabetic Neuropathy?’

Other contributions focusing on early detection and successful treatment of DPN are encouraged.

Keywords: Diabetes, Peripheral Neuropathy, Etiology, Intervention, Early Detection

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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