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Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
NCT03460769 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Objectives:
1. Evaluate the pancreatic polypeptide response following a standardized mixed meal in new onset diabetes associated with PDAC (particularly with a proximal tumor) and chronic pancreatitis vs. T2DM.
2. Evaluate the insulin and glucagon response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
3. Evaluate the incretin response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
4. Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases and long-standing DM or normoglycemia.
5. Evaluate differences in fasting levels of insulin and novel biomarkers in pancreatic cancer compared to chronic pancreatitis and T2DM.
6. Explore the metabolic alterations (including pancreatic polypeptide response and insulin secretion) in diabetes associated with pancreatic surgery for chronic pancreatitis.
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) \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].
Study design
Enrollment target: 775 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-04-01
Estimated completion: 2027-06-30
Last updated: 2025-11-25
Interventions
Other: Data Management and Monitoring
Primary outcomes
- • Protocol and Regulatory Compliance Monitoring of Regulatory Documents for Consortium Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) (3 years)
Sponsor
M.D. Anderson Cancer Center · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactYing Yuan, PHD · contact · yyuan@mdanderson.org · 713-745-9740
ContactSuresh Chari, MBBS · contact · stchari@mdanderson.org · 713-501-3714
InvestigatorSuresh Chari, MBBS · principal_investigator, M.D. Anderson Cancer Center
All locations (10)
Cedars-Sinai Medical CenterActive Not Recruiting
Los Angeles, California, United States
Stanford UniversityActive Not Recruiting
Stanford, California, United States
University of FloridaActive Not Recruiting
Gainesville, Florida, United States
Indiana UniversityActive Not Recruiting
Carmel, Indiana, United States
University of MinnesotaActive Not Recruiting
Minneapolis, Minnesota, United States
Mayo ClinicActive Not Recruiting
Rochester, Minnesota, United States
Ohio State UniversityActive Not Recruiting
Columbus, Ohio, United States
University of Pittsburgh Medical CenterActive Not Recruiting
Pittsburgh, Pennsylvania, United States
Baylor College of MedicineActive Not Recruiting
Houston, Texas, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States