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

急性胰腺炎联盟 1 型糖尿病数据协调中心

• 批准号: 10471067
• 负责人: Vernon M Chinchilli
• 金额: $ 176.91万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-17 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10471067
• 关键词: 3-Dimensional; Agreement; Artificial Intelligence; Atrophic; Biological Markers; Certification; Clinical Trials; Collection; Complication; Data; Data Analyses; Data Collection; Data Coordinating Center; Diabetes Mellitus; Early Diagnosis; Eligibility Determination; Endocrinologist; Enrollment; Evaluation; Evolution; Exocrine pancreatic insufficiency; Eye; Fatty acid glycerol esters; Funding; Gastroenterologist; Goals; Human; Image; Image Analysis; Imaging Techniques; Individual; Infiltration; Institutional Review Boards; Insulin-Dependent Diabetes Mellitus; Knowledge; Laboratories; Location; Longitudinal Studies; Magnetic Resonance Imaging; Manuscripts; Measurement; Measures; Metabolic; Metabolic dysfunction; Monitor; Morphology; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Pancreas; Pancreatic Diseases; Participant; Pathogenesis; Patients; Perfusion; Persons; Phenotype; Policies; Population; Prediabetes syndrome; Preparation; Process; Prospective Studies; Protocols documentation; Psoas Muscles; Publications; Reporting; Research Design; Risk; Risk Assessment; Safety; Sample Size; Serial Magnetic Resonance Imaging; Services; Shapes; Signal Transduction; Staging; Standardization; Statistical Data Interpretation; Testing; Texture; Training; Visit; acute pancreatitis; arm; clinical center; clinical practice; cyber security; data exchange; data management; deep learning algorithm; diabetic patient; experience; extracellular; follow-up; image archival system; image reconstruction; imaging biomarker; non-invasive imaging; pancreas imaging; radiologist; risk stratification; sarcopenia; tool

PROJECT SUMMARY / ABSTRACT According to recent reports, pancreatogenic DM, a known complication of acute pancreatitis, may occur more frequently than previously recognized. Currently, limited data exist on well-phenotyped post-AP subjects from prospective studies to confirm this information. The Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC) was formed in 2020 to fulfill this knowledge gap (RFA-DK-19-023). The primary longitudinal study of the T1DAPC is the DREAM study which is funded and will begin enrolling patients in September 2021. The IMMINENT study is being proposed as the imaging biomarker arm of the DREAM study. Patients who experienced AP will enroll in the DREAM study and a subset of those participants will enroll in the IMMINENT study to have serial MRI examinations at 3, 12, 24 and 33 months. Preliminary data suggest that certain features on MRI not currently used in clinical practice can be useful in risk the assessment of DM. The hypothesis of the IMMINENT is that by identifying parenchymal changes in post-AP patients, MR imaging can differentiate at-risk individuals from those who will remain euglycemic. To achieve this goal, we will use several quantitative MR imaging techniques to interrogate the parenchyma. In addition to the advanced MRI analysis, we will use artificial intelligence and deep learning algorithms to detect changes that are not visible to the human eye. Our purpose is to observe and understand the natural history of DM after AP and demonstrate that MR imaging can reflect underlying pathophysiologic changes and serve as a biomarker of DM. We believe data generated from IMMINENT will enhance our understanding of the pathogenesis of post-AP DM. If successful, we will develop a quantitative composite risk score using useful MRI features. This composite risk score can be used for monitoring the risk of metabolic dysfunction in practice or clinical trials. As part of the T1DAPC (a multicenter collaborative network), we propose an excellent opportunity to investigate the post-AP DM by incorporating dedicated pancreas radiologists, gastroenterologists, endocrinologists, a data coordinating center, MR image analysis, and AI labs.

项目概要/摘要 根据最近的报道，胰腺源性糖尿病（急性胰腺炎的一种已知并发症）可能会发生更多 比以前认识到的频率更高。目前，关于表型良好的 AP 后受试者的数据有限 前瞻性研究证实了这一信息。急性胰腺炎 1 型糖尿病联盟 (T1DAPC) 于 2020 年成立，旨在填补这一知识空白 (RFA-DK-19-023)。 T1DAPC 的初步纵向研究 是 DREAM 研究，该研究已获得资助，将于 2021 年 9 月开始招募患者。即将进行的研究 被提议作为 DREAM 研究的成像生物标志物。经历过 AP 的患者将参加 在 DREAM 研究中，其中一部分参与者将参加 IMMINENT 研究以进行系列 MRI 3、12、24 和 33 个月时进行检查。初步数据表明 MRI 的某些特征目前尚未实现 在临床实践中使用可用于评估 DM 的风险。迫在眉睫的假设是 通过 MR 成像识别 AP 后患者的实质变化，可以将高危人群与其他人群区分开来 谁将保持血糖正常。为了实现这一目标，我们将使用多种定量 MR 成像技术 询问实质。除了先进的 MRI 分析之外，我们还将使用人工智能和深度分析 学习算法来检测人眼不可见的变化。我们的目的是观察和 了解 AP 后 DM 的自然病程，并证明 MR 成像可以反映潜在的情况 病理生理变化并作为 DM 的生物标志物。我们相信即将产生的数据将 增强我们对 AP 后 DM 发病机制的了解。如果成功的话，我们将开发一个定量的 使用有用的 MRI 特征进行综合风险评分。该综合风险评分可用于监控以下风险： 实践或临床试验中的代谢功能障碍。作为 T1DAPC（多中心协作网络）的一部分， 我们提出了一个通过合并专用胰腺来研究 AP 后 DM 的绝佳机会 放射科医生、胃肠病学家、内分泌学家、数据协调中心、MR 图像分析和人工智能实验室。