CPDPC16-04: Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabeTes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)

K
Kieren Mather, MD

Primary Investigator

Overview

Diabetes mellitus 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 their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas.The goal of this study is to develop a test to distinguish these various causes of diabetes. To accomplish this goal, we will enroll a range of patients. Most of the patients enrolled for these groups will have developed diabetes within the last 3 years, but we will also enroll a small number of patients with longterm diabetes and normal blood sugars for comparison.

Description

The goal of this study is to develop a test to discriminate T3cDM from T2DM.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    pancreatic cancer,diabetes mellitus,pancreatic disease,pancreatitis
  • Age: Between 40 Years - 85 Years
  • Gender: All

Inclusion Criteria

Patients must have a diagnosis of one of the following based on study definitions

-New Onset Diabetes in subjects with Pancreatic Cancer (PDAC)

-New Onset Diabetes in subjects with Chronic Pancreatitis

-New Onset Diabetes in subjects without Pancreatic disease (i.e., T2DM)

-Long standing T2DM without Pancreatic disease

-Long standing diabetes in subjects with PDAC

-Long standing diabetes subjects with chronic pancreatitis

-non-diabetic subjects with PDAC

-non-diabetic subjects with chronic pancreatitis

-non-diabetic controls without Pancreatic disease

Exclusion Criteria

Patients 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 patient's ability to tolerate study interventions. Specifically, diabetes must be stable enough to permit holding diabetes medications following the criteria below: The following oral anti-diabetic agents will be held on the day of the meal tolerance test but may resume once test is completed: metformin, sulfonylureas, repaglinide or nateglinide, alpha-glucosidase inhibitors (acarbose, miglitol), pramlintide, colesevelam, bromocriptine Those on low doses of insulin (< 0.5 U/kg/day) will not take insulin on the day of study procedures. Subjects taking higher doses of insulin (≥0.5 unit/kg/day) will be excluded from this study. Subjects taking, DPP-4 inhibitors, SGLT2 inhibitors, or short acting GLP-1 analogs (Byetta [exenatide], Victoza [liraglutide], Adlyxin [lixisenatide]) will be asked not to take these medications on the day of the meal tolerance test (they can be taken the day before if taken in the morning; for those taking these medications in the afternoon or evening, they will be asked to withhold such dosing on the day prior to testing). Subjects on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Tanzeum [albiglutide], Trulicity [dulaglutide]) will be excluded from the study.

Patients currently receiving oral steroid medications

Hospitalization for acute pancreatitis within 2 months before study visit

Presence of one or more pancreatic cysts ≥2 cm in size

Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded)

Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure)

Previous treatment for pancreatic cancer, including chemotherapy or radiation

Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures

Previous diagnosis of gastroparesis

Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix)

Allergy or intolerance to ingredients in Boost drink


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022. Study ID: 1707548968 (GI-CPDPC-MATHER-DETECT)

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