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The Treatment of Painful Diabetic Neuropathy With Diet

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a whole-food, plant-based diet with no added oils can ease nerve pain. It compares the diet with standard medicine treatment for adults with type 2 diabetes or prediabetes who have painful nerve damage.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have type 2 diabetes with an A1c of 6.5 or higher, or prediabetes with an A1c of 5.7–6.4. A1c measures blood sugar over time.
  • Have nerve damage confirmed by EMG/NCS nerve tests, with a sural-to-radial test ratio of 0.21 or less.
  • Have nerve pain and reduced feeling.
  • Rate your pain at least 4 on a scale from 0 to 10.
  • Be able to understand and agree to take part.
  • Be able to attend follow-up visits.

Who can't join

  • Have a possible cause of nerve damage other than type 2 diabetes.
  • Have type 1 diabetes.
  • Have low vitamin B12, low folate, or another lack of nutrients.
  • Have a thyroid gland that does not work normally.
  • Have an autoimmune disease, where the body attacks itself, or an inflammatory disorder.
  • Have HIV/AIDS or multiple myeloma, a type of cancer.
  • Have been exposed to metals or toxic substances.
  • Have moderate to severe narrowing of the lower spine that causes nerve-related leg symptoms when standing or walking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NC