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)

Z
Zeb Saeed

Primary Investigator

Enrolling By Invitation
30-84 years
All
Phase N/A
1 Location

Brief description of study

What is the purpose of this 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Eligibility of study

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

  • Conditions: Chronic Pancreatitis, Diabetes Mellitus Type 3c, Pancreatic Cancer
  • Age: Between 30 Years - 84 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 28 Sep 2024. Study ID: GI-CPDPC-MATHER-DETECT, 1707548968, 10811
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