Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
3 other identifiers
observational
775
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
November 25, 2025
November 1, 2025
6.2 years
February 7, 2018
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protocol and Regulatory Compliance Monitoring of Regulatory Documents for Consortium Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor protocol and regulatory compliance at all participating institutions.
3 years
Study Arms (3)
Pancreatic Cancer
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).
Chronic Pancreatitis
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).
Type 3c Diabetes Mellitus
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).
Interventions
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer 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).
Eligibility Criteria
Participants recruited from external sites.
You may qualify if:
- 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
You may not qualify if:
- 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) \[Criterion is not applicable for PDAC Participants undergoing fasting only blood collection\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32610, United States
Indiana University
Carmel, Indiana, 46280, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hart PA, Kudva YC, Yadav D, Andersen DK, Li Y, Toledo FGS, Wang F, Bellin MD, Bradley D, Brand RE, Cusi K, Fisher W, Mather K, Park WG, Saeed Z, Considine RV, Graham SC, Rinaudo JA, Serrano J, Goodarzi MO. A Reduced Pancreatic Polypeptide Response is Associated With New-onset Pancreatogenic Diabetes Versus Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Apr 13;108(5):e120-e128. doi: 10.1210/clinem/dgac670.
PMID: 36404274DERIVED
Related Links
Biospecimen
Sample collection (CP and PDAC groups): During the mixed meal tests, blood samples will be collected at a fasting baseline (time 0 min), then 15, and 30 minutes following meal ingestion.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suresh Chari, MBBS
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2018
First Posted
March 9, 2018
Study Start
April 1, 2021
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
November 25, 2025
Record last verified: 2025-11