Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes, Vegan Diet
Conditions
Keywords
painful, diabetic, neuropathy, peripheral neuropathy, diabetes, diabetes type 2
Brief summary
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.
Detailed description
The primary objective of this study is to determine whether dietary modification can improve symptoms of painful diabetic neuropathy (PDN) in a randomized controlled trial. This will be a prospective, randomized controlled study comparing a dietary intervention with conventional medical management over a two-month period. Participants assigned to the conventional management group will have the option to cross over to the dietary intervention after two months, with additional outcomes assessed following crossover. The dietary intervention is based on a prior case series demonstrating improvement in PDN with a whole-food, plant-based diet excluding all animal products and added oils. Participants will eliminate meat (red and white), dairy, eggs, and added oils. Those in the dietary group will also be encouraged to attend an optional cooking class to support adherence. Conventional medical management will consist of optimized pharmacologic therapy, including antiepileptic agents (gabapentin or pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants, and over-the-counter options such as alpha-lipoic acid. Medications will be titrated to maximize pain relief while minimizing adverse effects. This study will be conducted without external funding.
Interventions
OTHERDiet
Plant-based diet
OTHERMedical management
Medication optimization
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) | 2 months | Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever. |
| Average pain on Numerical Rating Scale (NRS) | 2 months | Patient will be asked what his or her "average" pain has been over the last 3 days. This will be on the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever. |
| ≥50% improvement of pain | 2 months | Patient will be asked if his or her average pain over the past 3 days is ≥50% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever. |
| ≥75% improvement of pain | 2 months | Patient will be asked if his or her average pain over the past 3 days is ≥75% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Pain Score on Numerical Rating Scale (NRS) | 2 months | Patient will be asked what his or her worst pain is on a daily basis using the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever. |
| Numbness location | 2 months | Patient asked the following: How far up does your numbness go in both lower extremities: (circle one): 1. Toes 2. Mid foot 3. Entire foot 4. Ankle 5. Mid calf 6. Knee |
| Sleep | 2 months | Patient is asked the following questions. How is your sleep? Circle one: good moderate poor 1. How many hours are you sleeping a night? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Is your sleep improved since the start of study? \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (yes or no) |
| Diabetes medication | 2 months | Patient is asked: List your diabetes medications and doses. |
| Pain medication | 2 months | Patient is asked the following question. List your pain medications and doses. |
| % pain improvement | 2 months | Patient is asked: What percentage of has your pain improved compared to the start of the study? \_\_\_\_\_\_\_\_\_\_\_\_ (0% = no change to 100% complete relief of pain) |
| % numbness improvement | 2 months | What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement) |
| Increased function | 2 months | Have you been able to increase your function (walking, getting around, steadiness on feet)? \_\_\_\_\_\_\_\_\_ (yes or no) |
| Compliance with diet | 2 months | If you are in the diet group, how compliant have you been with your diet? Chose one: 1. 0% (not compliant at all) 2. 25% 3. 50% 4. 75% 5. 90% 6. 100% (completely compliant at all times) |
| Global impression of change | 2 months | Rate your global impression of change of your diabetic neuropathy (chose one): 1. Very much improved 2. Much improved 3. Moderately improved 4. Minimally improved 5. No change 6. Worse 7. Much worse 8. Very much worse |
| Weight | 2 months | Weight in pounds measured at baseline and two months. This is measured in clinic. |
| Blood pressure | 2 months | Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines. |
| Heart Rate | 2 months | Number of participants with abnormal heart rate (outside of normal 60-100/min) |
| Creatinine lab level | 2 months | Number of participants with abnormal creatinine lab level (above 1.3 for males, 1.1 for females) and correlating with estimated glomerular filtration rate which is based off creatinine, age and sex. Kidney function will be based on the National Kidney Foundation guidelines (KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease). |
| Lipid levels | 2 months | Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values. |
| Hemoglobin A1c | 2 months | Percent of patients with abnormal hemoglobin A1c. Abormal values are based on American Diabetes Association (normal \<5.7, pre-diabetes 5.7-6.4, diabetes ≥6.5). |
Countries
United States
Contacts
CONTACTWilliam J Beckworth, MD
CONTACTMary Stanford, Clinical Research Coordinator
Outcome results
None listed