The Treatment of Painful Diabetic Neuropathy With Diet
Recruiting now · Not applicable
Conditions studied: Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes, Vegan Diet
In brief
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.
Key facts
- Study ID
- NCT07509671
- Run by
- AdventHealth
- People needed
- 40
- Starts
- 2024-04-23
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- AdventHealth Hendersonville — Hendersonville, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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