CPDPC16-04/DETECT

Participating Institutions

  • Baylor College of Medicine

    • William Fisher

  • Cedars-Sinai Medical Center

    • Mark Goodarzi

  • Indiana University

    • Zeb Saeed, MD

  • Mayo Clinic

    • Yogish Kudva

  • Stanford University

    • Walter Park

  • The Ohio State's Wexner Medical Center

    • Philip Hart

  • University of Florida

    • Kenneth Cusi

  • University of Minnesota

    • Melena Bellin

  • University of Pittsburgh Medical Center

    • Dhiraj Yadav

  • New York University

  • Diane Simeone

  • OHSU

    • Brett Sheppard

Title

Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)

Study Co-Chairs

Study Overview

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).

Primary 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.

References

Hart PA, Andersen DK, Mather KJ, Castonguay AC, Bajaj M, Bellin MD, Bradley D, Contreras N, Habtezion A, Korc M, Kudva Y, Petrov MS, Whitcomb DC, Yadav D, Yuan Y, Rinaudo JAS, Srivastava S, Serrano J, Goodarzi MO. Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Pancreatogenic Diabetes Secondary to Pancreatic Cancer and Chronic Pancreatitis: Rationale and Methodology for the DETECT Study From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas, 47:1239-1243, 2018