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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03460769

Collaborator

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

452

Enrollment

Location

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Chronic Pancreatitis Diabetes Mellitus Type 3c	Other: Data Management and Monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

452 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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 pancreatic cancer and chronic pancreatitis (DETECT).	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 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).	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 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).	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 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).

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 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

Other: Data Management and Monitoring

Type 3c Diabetes Mellitus

Other: Data Management and Monitoring

Outcome Measures

Primary Outcome Measures

Protocol and Regulatory Compliance Monitoring of Regulatory Documents for Consortium Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) [3 years]
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor protocol and regulatory compliance at all participating institutions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
Patients must be ages ≥40 and <85.
Patients must have a diagnosis of one of the following based on study definitions;
New Onset Diabetes (<3 years) in subjects with Pancreatic Cancer (PDAC);
New Onset Diabetes (<9 years) in subjects with Chronic Pancreatitis;
New Onset Diabetes (<3 years) in subjects without Pancreatic disease (i.e., T2DM)
Long standing T2DM (≥3 years) without Pancreatic disease
Long standing diabetes (≥3 years) in subjects with PDAC
Long standing diabetes (≥9 years) subjects with chronic pancreatitis
non-diabetic subjects with PDAC
non-diabetic subjects with chronic pancreatitis
non-diabetic controls without Pancreatic disease

Exclusion Criteria:

Patients 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 patient's ability to tolerate study interventions.
Diabetes must be stable enough to permit holding diabetes medications following the criteria below:
Subjects taking higher doses of insulin (≥ 0.75 unit/kg/day).
Subjects in the non-pancreatic disease subgroup (i.e., T2DM) on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Ozempic [semaglutide], Trulicity [dulaglutide]). Conversely, the use of these medications is permitted for subjects in the CP and PDAC groups.
Patients currently receiving oral steroid medications.
Hospitalization for acute pancreatitis within 2 months before study visit (with the exception of subjects enrolled into the PDAC group as this may be a symptom of the disease).
The presence of a symptomatic cyst in subjects with CP. The presence of a cyst in subjects with pancreatic cancer is not an exclusion, including cancer arising from a mucinous cystic lesion.
Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure).
Previous treatment for pancreatic cancer, including chemotherapy or radiation.
Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
Previous diagnosis of gastroparesis.
Patients 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.