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.
All Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must have signed an authorization for the release of their protected health information.
Participants must be ages ≥30 and <85.
Participants must have a diagnosis of one of the following based on study definitions;
New Onset Diabetes (<3 years) in participants with Pancreatic Cancer (PDAC);
Participants must not have any significant medical illnesses (including diabetes) that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the Participant's ability to tolerate study interventions.
Diabetes not stable enough to permit holding of diabetes medications in Participants undergoing mixed meal tolerance testing.
Participants taking higher doses of insulin (≥0.75 unit/kg/day). [Criterion is not applicable for PDAC Participants undergoing fasting only blood collection]
Participants in the non-pancreatic disease subgroup on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Ozempic [semaglutide], Trulicity [dulaglutide]). [Criterion is not applicable for Participants in the CP and PDAC groups].
M.D. Anderson Cancer Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator