Quantitative biomarkers of T1D peripheral neuropathy using functional imaging

使用功能成像定量 T1D 周围神经病变的生物标志物

• 批准号: 8978785
• 负责人: MARK R BURGE
• 金额: $ 21.11万
• 依托单位: VISIONQUEST BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8978785
• 关键词: 21 year old; Affect; Age; Age-Years; American; Amputation; Ankle; Applications Grants; Biological Markers; Blood Pressure; Blood flow; Body mass index; Characteristics; Clinical; Clinical Research; Clinical Trials; Collection; Complications of Diabetes Mellitus; Data; Data Collection; Development; Devices; Diabetes Mellitus; Diabetic Foot; Diabetic Retinopathy; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Early Diagnosis; Enrollment; Foot Ulcer; Foundations; Functional Imaging; Heart Diseases; Image; Image Analysis; Imaging Device; Imaging Techniques; Individual; Insulin-Dependent Diabetes Mellitus; Intervention; Kidney Diseases; Lower Extremity; Measurement; Measures; Medicine; Methodology; Modeling; Modification; Monitor; Nature; Nerve; Neural Conduction; Neurons; Neuropathy; New Mexico; Non-Insulin-Dependent Diabetes Mellitus; Patients; Pattern; Peripheral Nervous System Diseases; Persons; Pharmaceutical Preparations; Phase; Physicians; Physiologic Thermoregulation; Pilot Projects; Population; Process; Protocols documentation; Recovery; Regulation; Research Personnel; Risk; Risk Assessment; Sensitivity and Specificity; Sensory; Signal Transduction; Skin; Solutions; Speed; Staging; Stimulus; Symptoms; Techniques; Technology; Testing; Time; Universities; Variant; Video Recording; base; cohort; diabetic; diabetic patient; disability; foot; imaging system; indexing; optical imaging; prototype; public health relevance; research study; response; type I and type II diabetes

 DESCRIPTION (provided by applicant): Diabetes affects an estimated 374 million people worldwide, including more than 25 million Americans. Diabetic patients are at risk for a wide array of complications, including heart disease, kidney disease (nephropathy), ocular diseases (diabetic retinopathy), and diabetic foot (peripheral neuropathy). Fifteen percent of diabetics wil develop a foot ulcer as a result of peripheral neuropathy during their lifetime. Foot ulcers are th main cause (85%) of lower extremity amputation in patients with diabetes. VisionQuest Biomedical LLC and the University of New Mexico (UNM) have formed a team to study a population of diabetics with and without diagnosed peripheral neuropathy in order to gain a better understanding of how a person's auto-thermo-regulation after a cold provocation reflects neuronal changes in peripheral neuropathy. The study will use standard clinical examinations, such as monofilament sensory tests, as well as less standard exam techniques, such as sympathetic skin response, to compare with dynamic infrared functional imaging. The functional infrared imaging techniques have been developed and applied by our group as part of a pilot study. A prototype functional thermal imaging device has been tested on a number of subjects that shows strong indications of its capacity to measure thermal regulation in the plantar foot, and demonstrates potential as a biomarker for accurate quantification of DPN changes/progression in type 1 (T1D) or type 2 diabetes (T2D). Our preliminary experimental data results produced highly compelling evidence that thermal-functional technology can detect differences between normal controls and diabetics with/or at risk for peripheral neuropathy. There are three specific aims to be accomplished in this grant application. The first aim is to establish a normative range for the functional response to thermal stimulus as measured by an infrared imaging device by studying 50 control subjects. In the second aim, we will study the variation in the thermally derived functional signal in 50 diabetics with diagnosed peripheral neuropathy. The third aim is to apply the protocol developed in Aim 1 to conduct a clinical study with 50 diagnosed subjects with diabetes without peripheral neuropathy. Features, such as recovery time, recovery pattern (both temporal and spatial), will be correlated with clinical diagnostic measurements, such as nerve conduction velocity tests and ankle-brachial index tests. Clinical examinations will be performed by our collaborating podiatrist.

 描述（由申请人提供）：估计全世界有 3.74 亿人患有糖尿病，其中包括超过 2500 万美国人。糖尿病患者面临多种并发症的风险，包括心脏病、肾脏疾病（肾病）、眼部疾病（糖尿病视网膜病变）。 ) ) 和糖尿病足（周围神经病变）。百分之十五的糖尿病患者在一生中会因周围神经病变而出现足部溃疡。 VisionQuest Biomedical LLC 和新墨西哥大学 (UNM) 组成了一个团队，对患有和未诊断出周围神经病变的糖尿病患者进行研究，以获得更好的结果。了解一个人在寒冷刺激后的自我体温调节如何反映周围神经病变的神经变化该研究将使用标准的临床检查，例如单丝感觉测试，以及不太标准的检查技术，例如交感神经检查。作为试点研究的一部分，功能性红外成像技术已在许多受试者上进行了测试，显示出强烈的迹象。它能够测量足底的热调节，并显示出作为准确量化 1 型 (T1D) 或 2 型糖尿病 (T2D) 的 DPN 变化/进展的生物标志物的潜力。我们的初步实验数据结果提供了非常令人信服的证据，表明热调节。 -功能性技术可以检测正常对照和患有/或有周围神经病变风险的糖尿病患者之间的差异。本次拨款申请要实现三个具体目标，第一个目标是建立对热刺激的功能反应的规范范围。通过研究 50 名对照受试者，我们将研究 50 名患有周围神经病变的糖尿病患者的热衍生功能信号的变化。第三个目标是应用目标 1 中开发的方案进行临床。与学习50 名诊断为无周围神经病变的糖尿病受试者的特征，例如恢复时间、恢复模式（时间和空间），将与临床诊断测量（例如神经传导速度测试和踝肱指数测试）相关联。由我们的合作足病医生执行。