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

Launched by M.D. ANDERSON CANCER CENTER · Mar 2, 2018

Keywords

ClinConnect Summary

The DETECT trial is studying a special mixed meal test to help doctors understand and diagnose a specific type of diabetes known as Type 3c diabetes. This type of diabetes can develop in people with pancreatic cancer or chronic pancreatitis, which is inflammation of the pancreas. The goal of the study is to see how well this test works in identifying and characterizing diabetes in patients with these conditions. While the study is led by researchers at MD Anderson Cancer Center, patients will be recruited from various external sites participating in the study.

To participate, you need to be between the ages of 30 and 85 and have been diagnosed with certain types of diabetes related to pancreatic disease or chronic pancreatitis. It's important that you are well-informed and agree to take part in the study. Participants will undergo a mixed meal tolerance test, where they will eat a specific meal while doctors monitor their blood sugar levels. This study is currently recruiting participants, but there are some health conditions that may prevent someone from joining, such as unstable diabetes or recent surgeries related to the pancreas. If you're interested or think you might be eligible, it’s a good idea to discuss it with your healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must have signed an authorization for the release of their protected health information.
• • Participants must be ages ≥30 and \<85.
• • Participants must have a diagnosis of one of the following based on study definitions;
• • New Onset Diabetes (\<3 years) in participants with Pancreatic Cancer (PDAC);
• • New Onset Diabetes (\<3 years) in participants with Chronic Pancreatitis;
• • New Onset Diabetes (\<3 years) in participants without Pancreatic disease (i.e., T2DM)
• • Long standing T2DM (≥3 years) without Pancreatic disease
• • Long standing diabetes (≥3 years) in participants with PDAC
• • Long standing diabetes (≥3 years) participants with chronic pancreatitis
• • non-diabetic participants with PDAC
• • non-diabetic participants with chronic pancreatitis
• • non-diabetic controls without Pancreatic disease
• Exclusion Criteria:
• • Participants 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 Participant's ability to tolerate study interventions.
• • Diabetes not stable enough to permit holding of diabetes medications in Participants undergoing mixed meal tolerance testing.
• • Participants taking higher doses of insulin (≥0.75 unit/kg/day). \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\]
• • Participants in the non-pancreatic disease subgroup on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon \[exenatide\], Ozempic \[semaglutide\], Trulicity \[dulaglutide\]). \[Criterion is not applicable for Participants in the CP and PDAC groups\].
• • Participants currently receiving oral steroid medications.
• • Hospitalization for acute pancreatitis within 2 months before study visit. \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\]
• • The presence of a symptomatic cyst in Participants with CP. \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection; this includes cancer arising from a mucinous cystic lesion\].
• • Any Participant with a known pancreatic cancer histologic subtype other than adenocarcinoma (e.g., Participants with pancreatic neuroendocrine tumors are excluded).
• • Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure). \[Criterion is not applicable for CP Participants with diabetes who have a history of pancreaticoduodenectomy, pancreaticojejunostomy, distal pancreatectomy, or Frey\].
• • Previous treatment for pancreatic cancer, including chemotherapy or radiation.
• • Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures. \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].
• • Previous diagnosis of gastroparesis. \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].
• • Participants 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 Participants undergoing mixed meal testing (see Appendix 13.9) \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].