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

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ClinicalTrials.gov Identifier: NCT03460769
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Pancreatic Cancer Chronic Pancreatitis Diabetes Mellitus Type 3c Other: Data Management and Monitoring

Study Type : Observational
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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).




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


Biospecimen Retention:   Samples With DNA
Blood samples collected at a fasting baseline (time -5 min & 0 min), then 15, 30, 45, 60, 90 and 120 minutes following meal stimulation.


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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from external sites.
Criteria

Inclusion Criteria:

1. 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.

2 Patients must be ages ≥40 and <85.

3 Patients must have a diagnosis of one of the following based on study definitions; New Onset Diabetes in subjects with Pancreatic Cancer (PDAC); New Onset Diabetes in subjects with Chronic Pancreatitis; New Onset Diabetes in subjects without Pancreatic disease (i.e., T2DM) Long standing T2DM without Pancreatic disease Long standing diabetes in subjects with PDAC Long standing diabetes subjects with chronic pancreatitis non-diabetic subjects with PDAC non-diabetic subjects with chronic pancreatitis non-diabetic controls without Pancreatic disease

Exclusion Criteria:

  1. 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. Specifically, diabetes must be stable enough to permit holding diabetes medications following the criteria below:

    The following oral anti-diabetic agents will be held on the day of the meal tolerance test but may resume once test is completed: metformin, sulfonylureas, repaglinide or nateglinide, alpha-glucosidase inhibitors (acarbose, miglitol), pramlintide, colesevelam, bromocriptine Those on low doses of insulin (< 0.5 U/kg/day) will not take insulin on the day of study procedures.

    Subjects taking higher doses of insulin (≥0.5 unit/kg/day) will be excluded from this study.

    Subjects taking, DPP-4 inhibitors, SGLT2 inhibitors, or short acting GLP-1 analogs (Byetta [exenatide], Victoza [liraglutide], Adlyxin [lixisenatide]) will be asked not to take these medications on the day of the meal tolerance test (they can be taken the day before if taken in the morning; for those taking these medications in the afternoon or evening, they will be asked to withhold such dosing on the day prior to testing).

    Subjects on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Tanzeum [albiglutide], Trulicity [dulaglutide]) will be excluded from the study.

  2. Patients currently receiving oral steroid medications.
  3. Hospitalization for acute pancreatitis within 2 months before study visit
  4. Presence of one or more pancreatic cysts ≥2 cm in size
  5. Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
  6. Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure).
  7. Previous treatment for pancreatic cancer, including chemotherapy or radiation.
  8. Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
  9. Previous diagnosis of gastroparesis.
  10. Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  11. Allergy or intolerance to ingredients in Boost drink.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460769


Contacts
Contact: Ziding Feng, PHD 713-745-9740 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ziding Feng, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03460769     History of Changes
Other Study ID Numbers: PA17-0674
1U01DK108328-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Chronic Pancreatitis
Diabetes Mellitus Type 3c
Data management

Additional relevant MeSH terms:
Diabetes Mellitus
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases