Trial Search Results

Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC, which are listed in the appended DETECT protocol. The data management systems, auditing, and monitoring effort are supported by the CDMC.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Stanford Investigator(s):

Intervention(s):

  • Other: Data Management and Monitoring

Eligibility


Inclusion Criteria:

1. 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.

2 Patients must be ages ≥40 and <85.

3 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:

   1. 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.

   2. Patients currently receiving oral steroid medications.

   3. Hospitalization for acute pancreatitis within 2 months before study visit

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

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

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

   7. Previous treatment for pancreatic cancer, including chemotherapy or radiation.

   8. Previous vagotomy or gastric surgery, including endoscopic gastric reduction
   procedures.

   9. Previous diagnosis of gastroparesis.

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

11. Allergy or intolerance to ingredients in Boost drink.

Ages Eligible for Study

40 Years - 84 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Judith Chuang
Recruiting