The Treatment of Painful Diabetic Neuropathy With Diet
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Diet, Medical management.
- Кому может быть актуально
- Состояния в реестре: Painful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes, Vegan Diet. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Diet
Plant-based diet - Другое Medical management
Medication optimization
Первичные конечные точки
- Numerical Rating Scale (NRS) [Срок оценки: 2 months]
- Average pain on Numerical Rating Scale (NRS) [Срок оценки: 2 months]
- ≥50% improvement of pain [Срок оценки: 2 months]
- ≥75% improvement of pain [Срок оценки: 2 months]
Вторичные конечные точки (12)
- Worst Pain Score on Numerical Rating Scale (NRS) [Срок оценки: 2 months]
- Numbness location [Срок оценки: 2 months]
- Sleep [Срок оценки: 2 months]
- Diabetes medication [Срок оценки: 2 months]
- Pain medication [Срок оценки: 2 months]
- % pain improvement [Срок оценки: 2 months]
- % numbness improvement [Срок оценки: 2 months]
- Increased function [Срок оценки: 2 months]
- Compliance with diet [Срок оценки: 2 months]
- Global impression of change [Срок оценки: 2 months]
- Weight [Срок оценки: 2 months]
- Blood pressure [Срок оценки: 2 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- AdventHealth Hendersonville — Hendersonville
Публикации
- 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
- 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. PMID 39415400
- 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. PMID 26011582
- 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.
Идентификаторы
NCT: NCT07509671 · 2102531