Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in aldose reductase enzyme levels
研究概览
简要总结
The purpose of this pilot study is to determine whether vitamin C supplementation is beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2 diabetes.
详细描述
Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting the feet, legs and hands that is often characterized as burning or a "pins and needles" sensation, is estimated to affect up to 66% of the U.S. diabetic population. This pilot study will examine the effect of a daily dose of ascorbic acid, a known aldose reductase inhibitor, versus placebo, and the effect that it can have on intracellular erythrocyte (red blood cell) sorbitol levels, aldose reductase activity and aldose reductase enzyme levels utilizing benchtop methods, and effects on clinical DPN-associated pain reporting and changes in quantitative sensory testing in the lower extremities via touch discrimination and vibratory sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the course of 90 days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •diabetic peripheral neuropathy
- •A1C of 6.0-10.0%
排除标准
- •Terminal diagnosis
- •Significant renal dysfunction
- •History of B-12 deficiency
- •Peripheral vascular disease
- •Current smoker
- •History of kidney stones
- •Current ascorbic acid use
- •Presence or foot infection and/or ulcer
结局指标
主要结局
Changes in aldose reductase enzyme levels
时间窗: Levels at 90 days compared to baseline
Changes in intracellular erythrocyte sorbitol levels
时间窗: Changes at 90 days compared to baseline
Changes in aldose reductase enzyme activity
时间窗: Activity at 90 days compared to baseline
次要结局
- Changes in Neuropathic Pain Scale (NPS) measurement and quantitative sensory testing in the lower extremities via touch discrimination with Semmes-Weinstein monofilaments and vibratory sensation testing(Changes at 90 days compared to baseline)
研究者
Joshua Neumiller
Professor
Washington State University