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The Treatment of Painful Diabetic Neuropathy With Diet

RecruitingNAAges 18 Years - anyAllAdventHealth
NCT07509671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function. This study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4) * objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less * presence of painful neuropathy in addition to decreased sensation * with pain rated ≥4/10 on a 0-10 numerical rating scale (NRS) * age 18 years or older * ability to provide informed consent * ability to attend follow-up visits. Exclusion Criteria: * Potential causes of neuropathy other than type II diabetes mellitus (as listed below) * type I diabetes * vitamin B12 deficiency * folate deficiency * thyroid dysfunction, * other nutritional deficiencies * autoimmune disorders * inflammatory disorders * HIV/AIDS * exposure to metals or toxins * multiple myeloma, * moderate to severe lumbar stenosis with neurogenic claudication
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What it tests

  • Diet
  • Medical management
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Where

1 site
AdventHealth Hendersonville
Hendersonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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