Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

摘要 1型糖尿病(T1D)可能发生在一种或多种急性胰腺炎之后或作为其结果 剧集。早期生物标记物、临床体征、疾病进展的生物标志物、免疫和 遗传危险因素、最易感亚群、诱发机制、急性胰腺炎的病因以及 T1D的相关病理生理学有助于提供治疗方面的最佳实践，以减少 T1D发作。回应国家糖尿病、消化和肾脏疾病研究所的RFA-DK-19- 023，公共卫生科学系(DPHS)和医学系(内分泌学和胃肠病学) 宾夕法尼亚州立大学医学院和阿勒格尼健康网络建议为 作为急性胰腺炎联盟1型糖尿病的数据协调中心(T1DAPC)。 1个DCC和10个临床中心(RFA-DK-19-022)将组成临床联盟T1DAPC。一种高效和 支持性DCC不仅协作开发所有文档并提供高效的统计数据 分析和试验主文件，来自DCC的结果构成了许多出版物的主干， 为随后的试验提供初步数据，并可能从临时、后期和 对研究中出现的问题进行了新的分析。DPHS拥有丰富的经验和专业知识，如 美国国立卫生研究院资助的10项临床试验和5个观察性研究研究网络的DCC，导致了更多 出版了200多种出版物，随后又提供了6笔赠款。我们在HIPAA兼容数据的DCC方面的丰富经验 多中心临床试验的汇编和分析横跨十几个治疗领域，可以 为分析种族和地理上不同的受试者群体提供更多洞察力 随着不同和重叠的临床特征的发展和分析，一些是在特别情况下建立的 开发和测试队列。DCC将汇总和分析所有常见数据元素和 以明确、简明、友好的方式提供科学基础设施和行政支持 T1DAPC联盟。DCC和临床中心将组成多学科团队，执行一项 一项前瞻性纵向观察研究，可确定与以下疾病相关的T1糖尿病发病率 急性胰腺炎发作，并评估与潜在的早期生物标志物，临床症状， 疾病进展的生物标记物，免疫和遗传风险因素，最敏感的亚组，沉淀 T1D或其他类型急性胰腺炎的机制、病因学和相关的病理生理学 糖尿病。发改委将收集、综合和传播主要调查结果和经验教训 T1DAPC父母和辅助研究，创建公共数据集，并根据 使用NIDDK和T1DAPC。

ABSTRACT Type 1 diabetes mellitus (T1D) may develop after, or as a consequence of, one or more acute pancreatitis episodes. Elucidation of early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D can help inform best practices in treatment for reducing incidence of T1D onset. In response to the National Institute of Diabetes and Digestive and Kidney Diseases’ RFA-DK-19- 023, the Departments of Public Health Sciences (DPHS) and Medicine (Endocrinology and Gastroenterology) at The Pennsylvania State University College of Medicine and the Allegheny Health Network propose to serve as the Data Coordinating Center (DCC) for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). One DCC and 10 Clinical Centers (RFA-DK-19-022) will form the clinical consortium, T1DAPC. An efficient and supportive DCC not only collaborates on development of all documentation and provides efficient statistical analyses and Trial Master File, the results from the DCC form the backbone of numerous publications, preliminary data for subsequent trials, and may lead to profound novel insights from ad-hoc, post-hoc, and newly formulated analyses to Questions arising during the study. DPHS has vast experience and expertise as the DCC for 10 NIH-funded clinical trial and five observational study research networks, which resulted in more than 200 publications, six subsequent grants. Our vast experience in DCC for HIPAA-compliant data compilation and analyses of multicenter clinical trials spans more than a dozen therapeutic areas and can provide additional insights for analysis of ethnically and geographically diverse population of subjects as well as development and analyses of distinct and overlapping clinical profiles, some being instituted post hoc with development and testing cohorts. The DCC will aggregate and analyze all common data elements and samples and provide scientific infrastructure and administrative support in a clear, concise, friendly manner for the T1DAPC Consortium. The DCC and the Clinical Centers will form multi-disciplinary teams that execute a prospective longitudinal observational study that can determine the incidence of T1 diabetes associated with an acute pancreatitis episode and assess relationships with potential early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D or other types of diabetes. The DCC will collect, synthesize, and disseminate main findings and lessons learned from the T1DAPC parent and ancillary studies, create public data sets, and share the biological samples in accordance with the NIDDK and T1DAPC.