The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial

What this Trial Is About

Researchers are evaluating whether targeted changes in diet can improve symptoms of painful diabetic neuropathy (PDN), a condition caused by reduced blood flow and oxygen to peripheral nerves leading to nerve damage. This randomized controlled trial compares the effects of a whole-food, plant-based diet without added oils to standard medication management for PDN. The study aims to better understand if dietary changes can enhance nerve function and reduce pain in people with type 2 diabetes-related neuropathy. Participants will be randomly assigned to one of two groups: a diet group following a whole-food, plant-based diet excluding all meat, dairy, eggs, and added oils, and a medication group receiving optimized pharmacologic treatment including drugs like gabapentin, pregabalin, duloxetine, and others. The diet group may also attend optional cooking classes to support adherence. After two months, those in the medication group can choose to switch to the diet intervention, with further outcomes assessed. During the study, participants will have regular assessments including pain ratings using the Numerical Rating Scale, evaluations of numbness, sleep quality, medication use, and function. Researchers will monitor health measures such as weight, blood pressure, heart rate, blood labs including hemoglobin A1c and lipid levels, and compliance with the diet. The primary outcome focuses on pain improvement after two months of intervention. The total study duration includes initial treatment and possible crossover periods with follow-up visits to track changes and safety.

The Treatment of Painful Diabetic Neuropathy With Diet