This clinical trial evaluates the mixed meal test to identify and diagnose diabetes mellitus (DM) secondary to chronic pancreatitis and pancreatic cancer. DM is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with the pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. This if often referred to as type 3c diabetes. Information gathered from this study may help researchers learn if the mixed meal test can identify diabetes secondary to chronic pancreatitis and pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03460769.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Suresh T Chari
Phone: 713-501-3714
PRIMARY OBJECTIVES:
I. Evaluate the pancreatic polypeptide response following a standardized mixed meal in new onset diabetes
associated with pancreatic ductal adenocarcinoma (PDAC) (particularly with a proximal tumor) and chronic pancreatitis versus (vs.) type 2 diabetes (T2DM).
II. Evaluate the insulin and glucagon response following a standardized mixed meal in new onset diabetes
associated with PDAC and chronic pancreatitis vs. T2DM.
III. Evaluate the incretin response following a standardized mixed meal in new onset diabetes associated
with PDAC and chronic pancreatitis vs. T2DM.
IV. Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases
and long-standing DM or normoglycemia.
V. Evaluate differences in fasting levels of insulin and novel biomarkers in pancreatic cancer compared to
chronic pancreatitis and T2DM.
VI. Explore the metabolic alterations (including pancreatic polypeptide response and insulin secretion) in
diabetes associated with pancreatic surgery for chronic pancreatitis.
OUTLINE: This is an observational study.
Patients undergo fasting finger stick glucose testing then consume a standard mixed meal of Boost (registered trademark) in equal portions. Patients also undergo blood sample collection throughout the study.
At completion of study intervention, patients are followed up at 12 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSuresh T Chari