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)

Study to Develop a Test for Identifying Causes of Diabetes

Recruiting
40 years - 85 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

The goal of this study is to develop a test to discriminate T3cDM from T2DM.
Participants will be compensated for their participation.

Eligibility of study

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

  • Conditions: pancreatic disease,pancreatic cancer,pancreatitis,diabetes mellitus
  • Age: 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

Updated on 19 Feb 2024. Study ID: 1707548968 (GI-CPDPC-MATHER-DETECT)

This study investigates the causes of diabetes related to the pancreas, such as chronic pancreatitis or pancreatic cancer, compared to type 2 diabetes. Diabetes mellitus is a condition characterized by high blood sugar levels. This study aims to develop a test to distinguish between diabetes caused by pancreatic issues and type 2 diabetes.

Participants will undergo various procedures to help develop this test. These procedures may involve holding certain diabetes medications on the day of a meal tolerance test. The study will include different study arms to compare participants with new onset diabetes, long-standing diabetes, and those without diabetes.

  • Who can participate: Adults who have been diagnosed with either new onset diabetes or long-standing diabetes, with or without pancreatic disease, are eligible. Non-diabetic individuals with or without pancreatic disease may also participate.
  • Study details: Participants will be involved in a meal tolerance test where some diabetes medications may need to be paused. Those on low doses of insulin may not take it on the day of the test. Participants will be compensated for their involvement.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here