Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Research Study | DETECT
CPDPC16-04 | DETECT
Protocol:
Protocol:
Currently there is no test to discriminate type 3c diabetes mellitus (T3cDM) from the much more prevalent type 2 diabetes (T2DM). The objective of DETECT is to evaluate a mixed meal test as a diagnostic method to distinguish patients with new onset diabetes secondary to pancreatic cancer (PDAC) and/or chronic pancreatitis (aka type 3c diabetes mellitus, T3cDM) from patients with T2DM. Participants with new onset DM associated with pancreatic cancer (n=136), chronic pancreatitis (n=136), or diabetes without known structural pancreatic disease (i.e., type 2 DM) (n=100) will undergo a mixed meal test. Each subject will undergo a 120 minute mixed meal test with serial sampling for later measurement of serum pancreatic polypeptide (PP) levels and other analytes. Intergroup differences in the relative PP response at 30 minutes (the primary endpoint) and other time points as well as the area under the curve will be compared. Enrollment for DETECT began in September 2018. As of July 2019, 9 clinical centers have enrolled 112 participants into the study. DETECT aims to establish an accurate and robust method to distinguish patients with T3cDM from patients with type 2 diabetes (T2DM).
Overview:
Abstract:
Pancreatogenic diabetes mellitus is most commonly the result of chronic pancreatitis, but can also occur secondary to pancreatic cancer. The early identification of pancreatogenic diabetes and distinction from the more prevalent type 2 diabetes is clinically significant; however, currently, there is no validated method to differentiate these diabetes subtypes. We describe a study, “Evaluation of a Mixed Meal Test for Diagnosis and Characterization of PancrEaTogEniC DiabeTes Secondary to Pancreatic Cancer and Chronic Pancreatitis: the DETECT study,” which seeks to address this knowledge gap. The DETECT study is a multicenter study that will examine differences in hormone and glucose excursions following a mixed meal test. The study will also create a biorepository that will be used to evaluate novel diagnostic biomarkers for differentiating these diabetes subtypes.
Abstract:
Abstract:
Diabetes mellitus (DM) secondary to an inherited or acquired disease of the exocrine pancreas is collectively termed pancreatogenic or type 3c diabetes mellitus (type 3c DM).1,2 The most commonly recognized causes of pancreatogenic DM are chronic pancreatitis and pancreatic ductal adenocarcinoma (PDAC), accounting for approximately 80% and 10% of cases, respectively (Fig. 1).3 The lifetime prevalence of DM in chronic pancreatitis can reach up to 80%, with a point prevalence of 40%.4,5 The prevalence is dependent on both patient and disease-related factors, including age, body mass index, family history, duration of pancreatic disease, presence of exocrine insufficiency, and pancreatic surgery.4,5 The prevalence of DM in PDAC at the time of diagnosis is ~50%, importantly 75% of these patients are diagnosed with DM within 2 years prior to the diagnosis of cancer.6 The overall prevalence of pancreatogenic DM amongst those with diabetes ranges from 2 to 9%.3,7,8 However, the true prevalence is difficult to determine due to the inability to differentiate it from the more prevalent type 2 DM (T2DM) and lack of validated diagnostic criteria. The primary purpose of the DETECT (Evaluation of a Mixed Meal Test for Diagnosis and Characterization of PancrEaTogEniC DiabeTes Secondary to Pancreatic Cancer and Chronic Pancreatitis) study is to develop a method to distinguish the two aforementioned subtypes of pancreatogenic diabetes from T2DM.
Objectives:
Evaluate the pancreatic polypeptide response following a standardized mixed meal in new-onset diabetes associated with pancreatic cancer (PDAC) and chronic pancreatitis (aka type 3c diabetes mellitus, T3cDM) vs. type 2 diabetes (T2DM).
Evaluate the insulin and glucagon response following a standardized mixed meal in new-onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
Evaluate the incretin response following a standardized mixed meal in new-onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases and long-standing DM or normoglycemia.
Objective:
Objective:
Phil A. Hart, MD, Dana K. Andersen, MD, Kieren J. Mather, MD, Alicia C. Castonguay, PhD, Mandeep Bajaj, MBBS, FRCP, Melena D. Bellin, MD, David Bradley, MD, MS, Noemy Contreras, MS, Aida Habtezion, MD, MSc, Murray Korc, MD, Yogish Kudva, MD, Maxim S. Petrov, MD, MPH, PhD, David C. Whitcomb, MD, PhD, Dhiraj Yadav, MD, MPH, Ying Yuan, PhD, Jo Ann Rinaudo, PhD, Sudhir Srivastava, PhD, MPH, Jose Serrano, MD, PhD, and on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
