The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •exposure to metals or toxins
- •multiple myeloma,
- •moderate to severe lumbar stenosis with neurogenic claudication
研究组 & 干预措施
Diet arm
This is a whole food plant-based diet that excludes meat, dairy, eggs and oil
干预措施: Diet (Other)
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.
干预措施: Medical management (Other)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Worst Pain Score on Numerical Rating Scale (NRS)(2 months)
- Numbness location(2 months)
- Sleep(2 months)
- Diabetes medication(2 months)
- Pain medication(2 months)
- % pain improvement(2 months)
- % numbness improvement(2 months)
- Increased function(2 months)
- Compliance with diet(2 months)
- Global impression of change(2 months)
- Weight(2 months)
- Blood pressure(2 months)
- Heart Rate(2 months)
- Creatinine lab level(2 months)
- Lipid levels(2 months)
- Hemoglobin A1c(2 months)