Natural History of Peripheral Diabetic Neuropathy

描述(申请人提供)：目前还没有客观的测量方法可以客观地评估小神经纤维的功能。目前使用的技术是依赖于患者合作的主观方法，这导致了高度的可变性。这阻碍了对能够特异性影响糖尿病神经病变中的小神经纤维的新治疗方法的评估，例如神经营养因子。本方案的主要目的是评价神经轴突相关血管扩张测量在量化C伤害性纤维功能和跟踪糖尿病相关功能障碍至少三年的进展方面的有效性。为此，我们计划对150名没有或有轻度神经病变的糖尿病患者和25名健康对照组进行跟踪调查。所有参与者将在至少36个月内每18个月见一次面。在每次就诊期间，将使用目前使用的方法对神经病进行评估，包括评估神经病症状评分(NSS)、神经损伤评分(NIS)、振动感知阈值(VPT)、温度测试和Semmes-Weinstein单丝。每次就诊时都会测量与神经轴突反射相关的血管扩张，这是一项可以评估C-伤害性纤维功能的客观指标。神经轴突相关血管扩张测量的变化将与目前可用的方法观察到的变化进行比较。希望本研究能为以下问题提供答案：1.糖尿病神经病变中小神经纤维功能下降的速度是多少？2.神经轴突相关血管扩张测量是否适用于参加临床试验以检验新疗法疗效的糖尿病患者的长期随访？3.需要多少患者和所需的时间才能使临床试验获得适当的动力？

DESCRIPTION (provided by applicant): There are currently no objective measurements that can objectively evaluate the function of small nerve fibers. The currently used techniques are subjective methods that rely on the patient's collaboration and this results to a high degree of variability. This hampers the assessment of new treatments that can specifically affect the small nerve fibers in diabetic neuropathy, such as neurotrophic factors. The main objective of the present proposal is to evaluate the efficacy of nerve axon-related vasodilation measurement in quantifying the function of C nociceptive fibers and following the progression of diabetes-related dysfunction over a period of at least three years. To this end, we plan to follow up 150 diabetic patients without and with mild neuropathy and 25 healthy control subjects. All participants will be seen every 18 months for a minimum of 36 months. During each visit, neuropathy will be assessed using currently employed methods that include the assessment of the Neuropathy Symptom Score (NSS), Neuropathy Impairment Score (NIS), Vibration Perception Threshold (VPT), thermal testing and Semmes-Weinstein monofilaments. The nerve axon reflex related vasodilation, an objective measurement that can evaluate the function of the C-nociceptive fibers, will be measured during each visit. The changes in the nerve axon-related vasodilation measurement will be compared to the changes that will be observed in the currently available methods. It is hoped that this study will provide answers to the following questions: 1. What is the rate of decline of the small nerve fiber function in diabetic neuropathy? 2. Is the nerve axon-related vasodilation measurement suitable for the long term follow-up of diabetic patients who participate in clinical trials that examine the efficacy of new treatments? 3. What are the required numbers of patients and the required length of time so a clinical trial is properly powered?