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RECRUITINGINTERVENTIONAL

The Treatment of Painful Diabetic Neuropathy With Diet

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - ability to attend follow-up visits. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Diet

Plant-based diet

OTHER

Medical management

Medication optimization

Locations (1)

AdventHealth Hendersonville
Hendersonville, North Carolina, United States