Type 1 Diabetes in Acute Pancreatitis Consortium - Clinical Centers (T1DAPC-CCs) (U01 Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) invites U01 applications for the establishment of a clinical consortium, composed of one Data Coordinating Center (DCC) and up to 10 Clinical Centers (CC), to conduct studies on diabetes mellitus, with an emphasis on Type 1 diabetes (T1D), that occurs after or as a consequence of one or more episodes of acute pancreatitis.

The Consortium will form multi-disciplinary teams composed of members from the CCs and DCC to undertake a prospective longitudinal observational study of the occurrence of diabetes that occurs during an acute pancreatitis episode or subsequently, with an emphasis on type 1 diabetes (T1D). The study will be designed to gain insight into the incidence, clinical evolution, etiology, type and pathophysiology of the T1D and other forms of diabetes that occurs during or after one or more episodes of acute pancreatitis. The teams will also undertake studies on the identification of immune and genetic risk factors and biomarkers which predict the development of T1D in a racially, ethnically, and geographically diverse population of subjects who have impaired glucose tolerance or diabetes mellitus after one or more episodes of acute pancreatitis due to various identifiable etiologies.

Applications for the Data Coordinating Center (DCC) will be submitted in response to a separate FOA: RFA-DK-19-023: Type 1 Diabetes in Acute Pancreatitis Consortium Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional).

To achieve the goal of a comprehensive characterization of diabetes with an emphasis on T1D that results or occurs after acute pancreatitis, each CC should include researchers and clinicians with multi-disciplinary expertise. CCs will be expected to share results freely within Consortium and to develop trans-consortium collaborative projects that make use of the combined expertise and technological capabilities present in all of the CCs.

In addition, a major collaborative effort within the Consortium will be the establishment of an annotated repository of bio-specimens (e.g., blood, saliva, urine, pancreatic and duodenal juice, stools and when feasible pancreatic tissue) to allow for the identification and validation of biomarkers for risk stratification, early detection, and to inform the development of future treatment strategies to prevent or reverse T1D after acute pancreatitis.

Application Instructions

N/A; Any party who is preparing an application for this opportunity please inform OR so that we can be sure that no more than one group in working on a submission.