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



Status:Recruiting
Conditions:Cancer, Cancer, Gastrointestinal, Gastrointestinal, Diabetes, Pancreatic Cancer
Therapuetic Areas:Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:40 - 84
Updated:10/7/2018
Start Date:November 1, 2017
End Date:November 2020
Contact:Ying Yuan, PHD
Email:yyuan@mdanderson.org
Phone:713-745-9740

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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.


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.
We found this trial at
1
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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