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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

775 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)

NCT05980221

Pancreatic Exocrine Insufficiency

UNKNOWN NA

Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

NCT03058926

Chronic Pancreatitis Diabetes Pancreatic Cancer

UNKNOWN

Surveillance of Pancreatic Health After Diabetes Diagnosis

NCT06803771

Diabetes Mellitus Pancreatic Cancer, Adult

RECRUITING NA

Role of Perfusion CT in Pancreatic Cancer

NCT01703650

Adenocarcinoma, Pancreas Neuroendocrine Carcinoma of Pancreas

UNKNOWN

Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations

NCT06041009

Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Elastase 1 +3 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer Chronic Pancreatitis Diabetes Mellitus Type 3c

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Data Management and Monitoring

Intervention Type OTHER

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).

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).

Data Management and Monitoring

Intervention Type OTHER

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).

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).

Data Management and Monitoring

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suresh Chari, MBBS

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.