DETECT

What is the Purpose of this Study?

This study focuses on patients who have chronic pancreatitis, pancreatic cancer, or no known pancreas disease. It is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis (when the pancreas is swollen and irritated all the time and affected by scarring) 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 purpose of this study is to develop a blood test to distinguish various causes of diabetes. To this end, researchers will enroll a range of patients; most have developed diabetes within the last 3 years, but the study will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. Participants will be asked to complete a questionnaire regarding their personal and family history, and a series of blood samples will be collected prior to and for 2 hours following consumption of a liquid nutritional supplement called Boost.

Eligibility

All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
Patients must be ages ≥30 and <85.
Patients must have a diagnosis of one of the following based on study definitions

Inclusion Criteria:

All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
Patients must be ages ≥30 and <85.
Patients must have a diagnosis of one of the following based on study definitions
New Onset Diabetes (<3 years) in subjects with Pancreatic Cancer (PDAC);
New Onset Diabetes (<3 years) in subjects with Chronic Pancreatitis;
New Onset Diabetes (<3 years) in subjects without Pancreatic disease (i.e., T2DM)
Long standing T2DM (≥3 years) without Pancreatic disease
Long standing diabetes (≥3 years) in subjects with PDAC
Long standing diabetes (≥3 years) subjects with chronic pancreatitis
non-diabetic subjects with PDAC
non-diabetic subjects with chronic pancreatitis
non-diabetic controls without Pancreatic disease

Exclusion Criteria:

Subjects 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.
Diabetes not stable enough to permit holding of diabetes medications in subjects undergoing mixed meal tolerance testing.
Subjects taking higher doses of insulin (≥0.75 unit/kg/day).
Subjects in the non-pancreatic disease subgroup (i.e., T2DM) on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Ozempic [semaglutide], Trulicity [dulaglutide]). Conversely, the use of these medications is permitted for subjects in the CP and PDAC groups.
Patients currently receiving oral steroid medications.
Hospitalization for acute pancreatitis within 2 months before study visit (with the exception of subjects enrolled into the PDAC group, as this may be a symptom of the disease).
The presence of a symptomatic cyst in subjects with CP. The presence of a cyst in subjects with pancreatic cancer is not an exclusion, including cancer arising from a mucinous cystic lesion.
Any subject with a known 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). An exception to this criterion are subjects with CP who had a history of surgery (including pancreaticoduodenectomy, pancreatic ojejunostomy, distal pancreatectomy, or Frey).
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 in subjects undergoing mixed meal testing

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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Pancreas

Principal Investigator

Goodarzi, Mark

Co-Investigators

Andrew Hendifar, Artak Labadzhyan, Christie Jeon, Jun Gong, Nicholas Nissen, Quin Liu, Ruchi Mathur, Simon Lo, Srinivas Gaddam, Stephen Pandol, Wendy Sacks

Age Group

Adult

Phase

N/A

IRB Number

Pro00050528

ClinicalTrials.gov ID

NCT03460769

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org