Rationale and Design for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

Hart, Phil A.; Papachristou, Georgios I.; Park, Walter G.; Dyer, Anne–Marie; Chinchilli, Vernon M.; Afghani, Elham; Akshintala, Venkata S.; Andersen, Dana K.; Buxbaum, James; Conwell, Darwin L.; Dungan, Kathleen; Easler, Jeffrey J.; Fogel, Evan L.; Greenbaum, Carla J.; Kalyani, Rita R.; Korc, Murray; Kozarek, Richard A.; Laughlin, Maren R.; Lee, Peter J.; Maranki, Jennifer; Pandol, Stephen J.; Phillips, Anna E.; Serrano, José; Singh, Vikesh K.; Speake, Cate; Tirkes, Temel; Toledo, Frederico G. S.; Trikudanathan, Guru; Vege, Santhi Swaroop; Wang, Ming; Yazıcı, Cemal; Zaheer, Atif; Forsmark, Christopher E.; Bellin, Melena D.; Yadav, Dhiraj

doi:10.1097/mpa.0000000000002079

Cited by 17 publications

(21 citation statements)

References 28 publications

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“…Participant inclusion and exclusion criteria are described in detail elsewhere 12 . Of note, participants with preexisting DM (ie, present before the qualifying AP episode) will not undergo follow-up with detailed metabolic testing because the objective of the study is to determine the metabolic changes that precede and lead to DM after AP.…”

Section: Methodsmentioning

confidence: 99%

Assessing the Pathophysiology of Hyperglycemia in the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

et al. 2022

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ObjectivesThe metabolic abnormalities that lead to diabetes mellitus (DM) after an episode of acute pancreatitis (AP) have not been extensively studied. This article describes the objectives, hypotheses, and methods of mechanistic studies of glucose metabolism that comprise secondary outcomes of the DREAM (Diabetes RElated to Acute pancreatitis and its Mechanisms) Study.MethodsThree months after an index episode of AP, participants without preexisting DM will undergo baseline testing with an oral glucose tolerance test. Participants will be followed longitudinally in three subcohorts with distinct metabolic tests. In the first and largest subcohort, oral glucose tolerance tests will be repeated 12 months after AP and annually to assess changes in β-cell function, insulin secretion, and insulin sensitivity. In the second, mixed meal tolerance tests will be performed at 3 and 12 months, then annually, and following incident DM to assess incretin and pancreatic polypeptide responses. In the third, frequently sampled intravenous glucose tolerance tests will be performed at 3 months and 12 months to assess the first-phase insulin response and more precisely measure β-cell function and insulin sensitivity.ConclusionsThe DREAM study will comprehensively assess the metabolic and endocrine changes that precede and lead to the development of DM after AP.

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Section: Methodsmentioning

confidence: 99%

Assessing the Pathophysiology of Hyperglycemia in the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

et al. 2022

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“…However, the working groups specific to the T1DAPC brought unique insight to the biorepository. The rationale and mechanisms of obtaining these samples are described in detail elsewhere 7,8 . Specifically, the immunology working group strongly supported the use of centralized and standardized processing of PBMC 9 to minimize the variability introduced by having multiple laboratories process these samples and to standardize processing and storage.…”

Section: Processmentioning

confidence: 99%

Standard Operating Procedures for Biospecimen Collection, Processing, and Storage

et al. 2022

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Differences in methods for biospecimen collection, processing, and storage can yield considerable variability and error. Therefore, best practices for standard operating procedures are critical for successful discovery, development, and validation of disease biomarkers. Here, we describe standard operating procedures developed for biospecimen collection during the DREAM (Diabetes RElated to Acute pancreatitis and its Mechanisms) Study within the Type 1 Diabetes in Acute Pancreatitis Consortium. Notably, these protocols were developed using an integrative process based on prior consortium experience and with input from working groups with expertise in immunology, pancreatitis, and diabetes. Publication and adoption consistent biospecimen protocols will inform future studies and allow for better comparisons across different metabolic research efforts.

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“…In alignment with standard DCC responsibilities, the DCC spearheaded the development of the DREAM sample size and statistical analysis plans. The primary outcome in the DREAM study is the time until onset of diabetes, 2,3 for which the DCC biostatisticians developed discrete-time and continuous-time hazards regression models. [4][5][6] The DCC also collaborated with the T1DAPC investigators in developing additional protocol content and the informed consent templates.…”

Section: Protocol Developmentmentioning

confidence: 99%

Rationale and Development of a Data Coordinating Center to Support the Type 1 Diabetes in Acute Pancreatitis Consortium

Dyer¹,

Baab²,

Merchlinski³

et al. 2022

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A data coordinating center (DCC) is a critical member of any multicenter research undertaking, and that is especially true for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). We describe how the T1DAPC DCC supports the consortium via its experience and expertise in project management, administration, financial management, regulatory compliance, scientific coordination, data management, research computing, and biostatistics and in facilitating scientific publications. The DCC's matrix management system has been extremely effective in managing all of its responsibilities. The first 16 months in the life of the T1DAPC have been dedicated to the development of its first protocol, titled Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM), addressing the institutional review board and regulatory components, developing the T1DAPC data management system, and providing training and certification of clinical center staff. As a result of its efforts, the DCC was a major contributor to the T1DAPC being able to initiate recruitment for the DREAM study in January 2022.

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Rationale and Design for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

Cited by 17 publications

References 28 publications

Assessing the Pathophysiology of Hyperglycemia in the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

Assessing the Pathophysiology of Hyperglycemia in the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

Standard Operating Procedures for Biospecimen Collection, Processing, and Storage

Rationale and Development of a Data Coordinating Center to Support the Type 1 Diabetes in Acute Pancreatitis Consortium

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