NCT07509671Recruiting
The Treatment of Painful Diabetic Neuropathy With Diet
The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- Apr 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- AdventHealth
- Diseases
- Type 2 diabetes
- NCT number
- NCT07509671
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Apr 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
- type I diabetes
- autoimmune disorders
- inflammatory disorders
- HIV/AIDS
Other
- vitamin B12 deficiency
- folate deficiency
- thyroid dysfunction,
- other nutritional deficiencies
- exposure to metals or toxins
- multiple myeloma,
- moderate to severe lumbar stenosis with neurogenic claudication
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AdventHealth Hendersonville Coordinator of this site? Confirm its status | Hendersonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.