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.

项目总结/摘要 根据最近的报道，胰源性DM，一种已知的急性胰腺炎并发症， 比以前认识到的更频繁。目前，有限的数据存在良好的表型后AP受试者， 前瞻性研究证实了这一信息。1型糖尿病急性胰腺炎联盟（T1 DAPC） 成立于2020年，以填补这一知识空白（RFA-DK-19-023）。T1 DAPC的初步纵向研究 是DREAM研究，该研究获得资助，将于2021年9月开始招募患者。迫在眉睫的研究 被提议作为DREAM研究的成像生物标志物分支。发生AP的患者将入组 在DREAM研究中，这些受试者的一部分将入组IMMINENT研究，接受系列MRI检查 在3、12、24和33个月时进行检查。初步数据表明，目前MRI上的某些特征 在临床实践中使用，可用于糖尿病的风险评估。假设的紧迫性是， 识别AP后患者的实质变化，MR成像可以区分高危个体和 血糖会保持正常为了实现这一目标，我们将使用几种定量磁共振成像技术， 询问软组织除了先进的MRI分析，我们还将使用人工智能和深度 学习算法来检测人眼看不到的变化。我们的目的是观察和 了解AP后DM的自然史，并证明MR成像可以反映潜在的 病理生理变化，并作为DM的生物标志物。我们相信，从IMMINENT生成的数据将 提高我们对AP后DM发病机制的认识。如果成功，我们将制定一个量化的 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测以下风险： 在实践或临床试验中的代谢功能障碍。作为T1 DAPC（多中心协作网络）的一部分， 我们提出了一个很好的机会，调查后AP糖尿病纳入专用胰腺 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AI实验室。