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.
|Effective start/end date||9/17/20 → 7/31/21|
- NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES: $2,322,833.00