TrialNet Pathway To Prevention (formerly Natural History Study)

TrialNet is a network of 19 clinical centers worldwide that conducts research on the study, prevention, and early treatment of type 1 diabetes (T1D). The TrialNet Pathway To Prevention (TN01) is a screening and monitoring study that was established to provide a source of subjects for enrollment into prevention trials. In addition, the prospectively followed cohort is used to gain new insights into the natural history of pre-type 1 diabetes in patients with increased risk for the disease. The primary aim of the study is to identify subjects for TrialNet prevention and investigation trials, but can also be used for assessing the predictive value of existing and novel risk markers of T1D, and for examining the demographic, immunologic, and metabolic characteristics of individuals at risk for developing T1D. Participants who are unaffected by T1D but who had a family member with TID and hence increased risk for developing the disease are eligible for enrollment. Screened subjects are tested for pancreatic autoantibodies (glutamic acid decarboxylase, insulin, ICA-512) using a blood screening test. Participants with at least one positive tests for any of the antibodies are eligible for confirmatory autoantibody measurements, and metabolic testing including oral glucose tolerance tests (OGTTs). Subjects under age 18 are re-screened annually, and subjects with some risk for disease can be enrolled in prevention trials or followed prospectively. Data collected on patients recruited through 2020 are available from the Repository.TrialNet是由全球19家临床中心组成的研究网络，专注于1型糖尿病（type 1 diabetes, T1D）的相关研究、预防与早期治疗工作。TrialNet预防通路研究（TN01）是一项筛查与监测类研究，其设立初衷是为预防试验招募受试者提供稳定的受试者来源。此外，该前瞻性随访队列还可为解析高患病风险人群的前驱1型糖尿病自然病程提供新的研究视角。本研究的核心目标是为TrialNet的预防试验与探索性研究招募受试者，同时也可用于评估现有及新型T1D风险标志物的预测价值，以及分析罹患T1D风险人群的人口学、免疫学与代谢特征。 未罹患1型糖尿病，但家族成员患有T1D（原文此处原标注为TID，疑为笔误），因此患病风险升高的人群，符合本研究的入组标准。入组受试者需通过血液检测筛查胰腺自身抗体，涵盖谷氨酸脱羧酶、胰岛素及ICA-512。仅检出至少一种自身抗体呈阳性的受试者，可进入确证性自身抗体检测及包括口服葡萄糖耐量试验（oral glucose tolerance tests, OGTT）在内的代谢功能评估。18岁以下的受试者需每年接受复筛，存在一定患病风险的受试者可纳入TrialNet的预防试验，或进行前瞻性随访。 截至2020年招募的患者相关研究数据，可通过本研究的数据存储库获取。