Evaluation Of A Mixed Meal Test For Diagnosis And Characterization And Type 3c Diabetes Mellitus Secondary To Pancreatic Cancer And Chronic Pancreatitis (DETECT)

Study Overview

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

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.

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.

Pancreatic Cancer
Chronic Pancreatitis
Diabetes Mellitus Type 3c

OTHER: Data Management and Monitoring

2020-0742 (PA17-0674)
1U01DK108328-01 (U.S. NIH Grant/Contract)
NCI-2018-02275 (OTHER Identifier) (OTHER: NCI-Clinical Trials Registry)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-20
First Submitted that Met QC Criteria 2018-03-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-24
First Posted (ACTUAL) 2018-03-09	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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 panc	OTHER: Data Management and Monitoring 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 c
: 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 panc	OTHER: Data Management and Monitoring 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 c
: 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 panc	OTHER: Data Management and Monitoring 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 c

Participant Group/Arm

Intervention/Treatment

: Pancreatic Cancer

OTHER: Data Management and Monitoring

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 c

: Chronic Pancreatitis

OTHER: Data Management and Monitoring

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 c

: Type 3c Diabetes Mellitus

OTHER: Data Management and Monitoring

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 c

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ying Yuan, PHD

Phone Number: 713-745-9740

Email: yyuan@mdanderson.org

Study Contact Backup

Name: Suresh Chari, MBBS

Phone Number: 713-501-3714

Email: stchari@mdanderson.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
30 Years

Accepts Healthy Volunteers:

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

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].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

PRINCIPAL_INVESTIGATOR: Suresh Chari, MBBS, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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