The Treatment of Painful Diabetic Neuropathy With Diet

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Potential causes of neuropathy other than type II diabetes mellitus (as listed below)

type I diabetes

vitamin B12 deficiency

folate deficiency

Trial design

Treatments tested in this trial

  • Diet
  • Medical management

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators