Standardization of C-Peptide and HbA1C (UC4)

C 肽和 HbA1C (UC4) 标准化

• 批准号: 8386855
• 负责人: Randie Little
• 金额: $ 217.26万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8386855
• 关键词: Affect; American; Beta Cell; Biological Assay; Biological Preservation; Blood Glucose; Blood Vessels; C-Peptide; Calibration; Capillary Electrophoresis; Cell physiology; Certification; Chronic; Chronic Disease; Clinical; Clinical Chemistry; Clinical Trials; Communities; Complications of Diabetes Mellitus; Data; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Disease Progression; Effectiveness; Evaluation; Eye; Fostering; Future; Glycosylated hemoglobin A; Goals; Heart; Hyperglycemia; Insulin; Insulin-Dependent Diabetes Mellitus; International; Intervention; Joints; Kidney; Laboratories; Manufacturer Name; Measurement; Measures; Medicine; Methods; Monitor; Normal Range; Outcome Measure; Pathologist; Patients; Peripheral Nerves; Production; Publishing; Research; Risk; Running; Serum; Standardization; Testing; Therapeutic Intervention; Time; Update; Variant; Work; blood glucose regulation; college; diabetes control; diabetes mellitus therapy; glycemic control; high risk; improved; meetings; member; programs; tool; web site

DESCRIPTION (provided by applicant): Diabetes mellitus is a chronic disorder characterized by insulin deficiency, hyperglycemia, and high risk for development of complications of the eyes, kidneys, peripheral nerves, heart and blood vessels. The disease is highly prevalent, affecting nearly 26 million people in the U.S. The landmark nine-year Diabetes Control and Complications Trial (DCCT), completed in 1993, showed conclusively that the risk for development and progression of the chronic complications in patients with type 1 diabetes mellitus could be dramatically reduced with improved blood glucose control as assessed by serial HbA1c determinations. HbA1c measurement standardization has become even more important in recent years for two reasons; first, there is increased use of the test, with rising rates of diabees and second, the test has recently been recommended for use in diabetes diagnosis. In addition, the FDA has utilized improvements in HbA1c as an outcome measure for approval of new therapies for diabetes. Thus there is now a critical need for accuracy and precision near the normal range in addition to the clinical target range for diabetes treatment. DCCT established the importance of another key laboratory measurement in type 1 diabetes. C-peptide is a stable and detectable non-functional cleavage product of insulin found in serum. Measurement of C-peptide is used to monitor endogenous insulin production in people with diabetes who are receiving exogenous insulin as therapy. There is increasing evidence, including data from the DCCT study, that preservation of even a low level of endogenous insulin production in people with type 1diabetes is associated with significantly fewer diabetes complications. Measuring C-peptide levels with highly sensitive and standardized methods is therefore important now to accurately implement and interpret clinical trials to identify therapeutic interventions capable of reversing or delaying progression of the disease at onset. Improving, harmonizing, and standardizing C-peptide measurements could be even more important in the future as additional interventions and combination of agents are tested for clinical benefit. This application if for continued implementation of standardization programs for both HbA1c and C-peptide. PUBLIC HEALTH RELEVANCE: The importance of HbA1c as a marker of glycemic control in diabetes mellitus, and more recently as a diagnostic tool, has been established. This proposed project will improve the measurement of HbA1c for optimal clinical and diagnostic use. Preservation of beta cell function in type 1diabetes has been identified as an important goal in delaying progression of the disease at onset and also for therapeutic intervention. Accurate, standardized measurement of C- peptide will aid in this goal and is also the subject of this application.

描述（由申请人提供）：糖尿病是一种以胰岛素缺乏、高血糖为特征的慢性疾病，具有眼睛、肾脏、周围神经、心脏和血管并发症的高风险。这种疾病非常普遍，在美国影响了近2600万人。1993年完成的具有里程碑意义的9年糖尿病控制和并发症试验（DCCT）最终表明，通过一系列HbA1c测定评估，改善血糖控制可以显著降低1型糖尿病患者慢性并发症的发生和进展风险。近年来，糖化血红蛋白测量标准化变得更加重要，原因有二：首先，随着糖尿病发病率的上升，该测试的使用有所增加；其次，该测试最近被推荐用于糖尿病诊断。此外，FDA已将HbA1c的改善作为批准糖尿病新疗法的结果衡量标准。因此，除了糖尿病治疗的临床目标范围外，现在迫切需要接近正常范围的准确性和精度。DCCT确立了另一项关键实验室测量在1型糖尿病中的重要性。c肽是血清中胰岛素的一种稳定的、可检测的非功能性裂解产物。在接受外源性胰岛素治疗的糖尿病患者中，测量c肽可用于监测内源性胰岛素的产生。越来越多的证据，包括来自DCCT研究的数据，表明1型糖尿病患者即使保持低水平的内源性胰岛素产生也与显著减少糖尿病并发症相关。因此，用高度敏感和标准化的方法测量c肽水平对于准确地实施和解释临床试验以确定治疗干预措施是非常重要的