The Treatment of Painful Diabetic Neuropathy With Diet

Part of paid clinical trials in Hendersonville, North Carolina.

Sponsor
AdventHealth
Study ID
NCT07509671
Status
Recruiting
Apply to this trial

Conditions

  • Painful Diabetic Neuropathy (PDN)
  • Peripheral Neuropathy With Type 2 Diabetes
  • Vegan Diet

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diet — OTHER
    Plant-based diet
  • Medical management — OTHER
    Medication optimization

Study Details

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 Dates

Start date
Apr 23, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Diet arm
    This is a whole food plant-based diet that excludes meat, dairy, eggs and oil
  • Experimental: medical managment
    This approach reflects standard pharmacologic management of diabetic peripheral neuropathy. Commonly used medications include antiepileptic agents (gabapentin, pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), and over-the-counter options such as alpha-lipoic acid and turmeric.

Primary Outcome Measure

Numerical Rating Scale (NRS) [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth HendersonvilleHendersonvilleNorth Carolina28759
Mary Stanford, Clinical Research Coordinator
[email protected]
828-654-8546
William J Beckworth, MD (PRINCIPAL_INVESTIGATOR)
Sven Jonsson, MD (SUB_INVESTIGATOR)

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AdventHealth Hendersonville· Hendersonville, NC

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