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

Pancreatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03460769
• Other study ID #: 2020-0742 (PA17-0674)
• Secondary ID: 1U01DK108328-01N
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Ying Yuan, PHD
• Phone: 713-745-9740
• Email: yyuan[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 84 Years

Eligibility

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 =30 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 (<3 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 (=3 years) subjects with chronic pancreatitis

• non-diabetic subjects with PDAC

• non-diabetic subjects with chronic pancreatitis

• non-diabetic controls without Pancreatic disease

Exclusion Criteria:

• Subjects 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 not stable enough to permit holding of diabetes medications in subjects undergoing mixed meal tolerance testing.

• 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 known 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). An exception to this criterion are subjects with CP who had a history of surgery (including pancreaticoduodenectomy, pancreatic ojejunostomy, distal pancreatectomy, or Frey).

• 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 in subjects undergoing mixed meal testing

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes Mellitus
• Diabetes Mellitus Type 3c
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center