Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Summary
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC, which are listed in the appended DETECT protocol. The data management systems, auditing, and monitoring effort are supported by the CDMC.
Detailed description
Objectives: 1. Evaluate the pancreatic polypeptide response following a standardized mixed meal in new onset diabetes associated with PDAC (particularly with a proximal tumor) and chronic pancreatitis vs. T2DM. 2. Evaluate the insulin and glucagon response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM. 3. Evaluate the incretin response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM. 4. Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases and long-standing DM or normoglycemia. 5. Evaluate differences in fasting levels of insulin and novel biomarkers in pancreatic cancer compared to chronic pancreatitis and T2DM. 6. Explore the metabolic alterations (including pancreatic polypeptide response and insulin secretion) in diabetes associated with pancreatic surgery for chronic pancreatitis.
Arms & interventions
- OtherData Management and Monitoring
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC).
Outcome measures
Primary
Protocol and Regulatory Compliance Monitoring of Regulatory Documents for Consortium Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor protocol and regulatory compliance at all participating institutions.
Time frame: 3 years
Eligibility criteria
Study locations (10)
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Stanford University
Stanford, California, 94305
University of Florida
Gainesville, Florida, 32610
Indiana University
Carmel, Indiana, 46280
University of Minnesota
Minneapolis, Minnesota, 55454
Mayo Clinic
Rochester, Minnesota, 55905
Ohio State University
Columbus, Ohio, 43210
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Baylor College of Medicine
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
References
- Hart PA, Kudva YC, Yadav D, Andersen DK, Li Y, Toledo FGS, Wang F, Bellin MD, Bradley D, Brand RE, Cusi K, Fisher W, Mather K, Park WG, Saeed Z, Considine RV, Graham SC, Rinaudo JA, Serrano J, Goodarzi MO. A Reduced Pancreatic Polypeptide Response is Associated With New-onset Pancreatogenic Diabetes Versus Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Apr 13;108(5):e120-e128. doi: 10.1210/clinem/dgac670.(PubMed)