Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Type 3c diabeTes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006548
Sponsor Protocol Number: CPDPC16-04
About 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 long-term diabetes and normal blood sugars for comparison.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 ≥ 40 and < 85 years old
- 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 (< 9 years) in subjects with Chronic Pancreatitis;
- New Onset Diabetes (<3 years) in subjects without Pancreatic disease (i.e., T2DM);
- Long standing T2DM (> 3 years) in subjects without Pancreatic disease;
- Long standing diabetes (>3 years) in subjects with PDAC;
- Long standing diabetes (> 9 years) in 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.
- 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 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yogish Kudva, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available