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.
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.
Study Type
OBSERVATIONAL
Enrollment
775
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).
Cedars-Sinai Medical Center
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGStanford University
Stanford, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Florida
Gainesville, Florida, United States
ACTIVE_NOT_RECRUITINGIndiana University
Carmel, Indiana, United States
ACTIVE_NOT_RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
ACTIVE_NOT_RECRUITINGMayo Clinic
Rochester, Minnesota, United States
ACTIVE_NOT_RECRUITINGOhio State University
Columbus, Ohio, United States
ACTIVE_NOT_RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGBaylor College of Medicine
Houston, Texas, United States
ACTIVE_NOT_RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGProtocol 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
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