Evaluating a mixed meal test for diagnosing diabetes related to pancreatic cancer and chronic pancreatitis

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

This study is testing how the body reacts to a mixed meal in people with new diabetes linked to pancreatic cancer or chronic pancreatitis to see how it compares to those with Type 2 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 775 (estimated)
• Ages: 30 Years to 84 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT03460769 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pancreatic polypeptide, insulin, glucagon, and incretin responses following a standardized mixed meal in patients with new onset diabetes associated with pancreatic cancer and chronic pancreatitis. It will compare these responses to those in patients with Type 2 Diabetes Mellitus (T2DM) and explore differences in metabolic alterations and biomarkers. The study is coordinated by the Coordinating and Data Management Center at MD Anderson Cancer Center, with patient recruitment occurring at external sites within the NIH-funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 30-85 with new onset diabetes related to pancreatic cancer or chronic pancreatitis, as well as those with long-standing diabetes or non-diabetic individuals with these conditions.

Not a fit: Patients with diabetes not related to pancreatic conditions or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for Type 3c diabetes, enhancing patient management and treatment outcomes.

How similar studies have performed: While this approach is part of a broader NIH-funded consortium, the specific mixed meal test for diagnosing Type 3c diabetes in this context is relatively novel.

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) \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].

Where this trial is running

Los Angeles, California and 9 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Active_not_recruiting)
• Stanford University — Stanford, California, United States (Active_not_recruiting)
• University of Florida — Gainesville, Florida, United States (Active_not_recruiting)
• Indiana University — Carmel, Indiana, United States (Active_not_recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Active_not_recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Active_not_recruiting)
• Ohio State University — Columbus, Ohio, United States (Active_not_recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Active_not_recruiting)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Suresh Chari, MBBS — M.D. Anderson Cancer Center
• Study coordinator: Ying Yuan, PHD

Conditions Pancreatic Cancer; Chronic Pancreatitis; Diabetes Mellitus Type 3c; Data management