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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet arm | Experimental | This is a whole food plant-based diet that excludes meat, dairy, eggs and oil |
|
| medical managment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Plant-based diet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever. | 2 months |
| Average pain on Numerical Rating Scale (NRS) | 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. | 2 months |
| ≥50% improvement of pain | 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. | 2 months |
| ≥75% improvement of pain | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Pain Score on Numerical Rating Scale (NRS) | 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. | 2 months |
| Numbness location |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William J Beckworth, MD | Contact | 828-654-8546 | william.beckworth.md@adventhealth.com | |
| Mary Stanford, Clinical Research Coordinator | Contact | 828-654-8546 | mary.stanford@adventhealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Hendersonville | Recruiting | Hendersonville | North Carolina | 28759 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Storz MA, Küster O. Plant-based diets and diabetic neuropathy: A systematic review. Lifestyle Med. 2020; 1:e6. https://doi.org/10.1002/lim2.6 | ||
| 39415400 | Background | Guest NS, Raj S, Landry MJ, Mangels AR, Pawlak R, Senkus KE, Handu D, Rozga M. Vegetarian and Vegan Dietary Patterns to Treat Adult Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2024 Oct;15(10):100294. doi: 10.1016/j.advnut.2024.100294. Epub 2024 Sep 30. | |
| 26011582 |
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All IPD that underlie results in a publication.
From start to finish. Anticipated finish date for data collection is December 2027 and publication by mid 2028
Access criteria will be based on those who are involved with the study or have oversight of study. This will include principle investigators, research coordinators, statisticians, IRB, research institute or any monitoring bodies.
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D000095500 | Diet, Plant-Based |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004035 | Diet Therapy |
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| Medical management | Other | Medication optimization |
|
Patient asked the following:
How far up does your numbness go in both lower extremities: (circle one):
| 2 months |
| Sleep | Patient is asked the following questions. How is your sleep? Circle one: good moderate poor
| 2 months |
| Diabetes medication | Patient is asked: List your diabetes medications and doses. | 2 months |
| Pain medication | Patient is asked the following question. List your pain medications and doses. | 2 months |
| % pain improvement | 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) | 2 months |
| % numbness improvement | What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement) | 2 months |
| Increased function | Have you been able to increase your function (walking, getting around, steadiness on feet)? _________ (yes or no) | 2 months |
| Compliance with diet | If you are in the diet group, how compliant have you been with your diet? Chose one:
| 2 months |
| Global impression of change | Rate your global impression of change of your diabetic neuropathy (chose one):
| 2 months |
| Weight | Weight in pounds measured at baseline and two months. This is measured in clinic. | 2 months |
| Blood pressure | Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines. | 2 months |
| Heart Rate | Number of participants with abnormal heart rate (outside of normal 60-100/min) | 2 months |
| Creatinine lab level | 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). | 2 months |
| Lipid levels | Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values. | 2 months |
| Hemoglobin A1c | 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). | 2 months |
| Background |
| Bunner AE, Wells CL, Gonzales J, Agarwal U, Bayat E, Barnard ND. A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study. Nutr Diabetes. 2015 May 26;5(5):e158. doi: 10.1038/nutd.2015.8. |
| Background | Crane M, Sample C. Regression of diabetic neuropathy with total vegetarian (vegan) diet. Journal of Nutritional Medicine. 1994;4(4):431-439. https://doi.org/10.3109/13590849409003592. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |