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A Study to Establish a New Onset Diabetes Cohort (NOD)

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ClinicalTrials.gov Identifier: NCT03731637
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Suresh T. Chari, M.D., Mayo Clinic

Brief Summary:
Create a large biobank of blood samples and data from subjects with new onset diabetes (NOD).

Condition or disease
Diabetes Type2 Diabetes Diabetes Mellitus

Detailed Description:
A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 3 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for NOD.

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Establish a New Onset Diabetes (NOD) Cohort
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Group/Cohort
New-onset diabetes
Subjects with biochemically-defined new-onset diabetes



Primary Outcome Measures :
  1. Incidence of pancreatic ductal adenocarcinoma in new-onset diabetes [ Time Frame: 3 years ]
    Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset diabetes.

  2. Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset diabetes [ Time Frame: 3 years ]
    We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing.


Biospecimen Retention:   Samples With DNA
Research Blood Collection


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who newly meet criteria for diabetes
Criteria

Inclusion Criteria:

  • Must have at least (1) Parameter of Diabetes Mellitus in the past 90 days;

    • Fasting Blood Glucose (FBG) Greater than 126mg/dl
    • Hemoglobin A1c (HbA1c) Greater than 6.5%
    • Random Blood Glucose (RBG) Greater than 200mg/dl
    • 2h Post Glucose (PG) Greater than 200mg

Exclusion Criteria:

  • Patient has had Diabetes Mellitus for great than 90 days
  • No glycemic parameters (fasting glucose, HbA1c) measured and available for review in past 18 months
  • On active treatment for cancer, current diagnosis of any cancer, past history of pancreatic cancer
  • Currently taking chronic or acute oral steroids

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): NCT03731637


Contacts
Contact: Sarah Nguyen, MPH, MSW 206-667-2258 sarah.nguyen@fredhutch.org

Locations
United States, California
Kaiser Permanente Southern California Recruiting
Los Angeles, California, United States, 90027
Contact: Bechien Wu, MD    323-783-7890    Bechien.U.Wu@kp.org   
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Stephen Pandol, MD    310-423-6082    stephen.pandol@cshs.org   
Kaiser Permanente Northern California Not yet recruiting
Oakland, California, United States, 94612
Contact: Stephen Van Den Eeden, MD    510-591-3718    Stephen.VanDenEeden@kp.org   
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94605
Contact: Walter Park, MD    650-723-4102    wgpark@stanford.edu   
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Steven Hughes, MD    352-265-0761    Steven.Hughes@surgery.ufl.edu   
United States, Indiana
Univeristy Hospital, Indian University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kieren Mather, MD    317-278-7826    kmather@iu.edu   
United States, Michigan
St. Joseph Mercy Health System Not yet recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Tareq Al Baghdadi, MD    732-712-1000    tareq_albaghdadi@ihacares.com   
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Suresh Chari, MD    507-255-5713    Chari.Suresh@mayo.edu   
Principal Investigator: Suresh Chari, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: David Bradley, MD    614-685-3333    david.bradley@osumc.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Randall Brand, MD    412-623-0021    brandre@upmc.edu   
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: William Fisher, MD    713-798-4321    wfisher@bcm.edu   
Sponsors and Collaborators
Mayo Clinic
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Chair: Suresh Chari, MD Mayo Clinic
Study Chair: Anirban Maitra, MBBS M.D. Anderson Cancer Center

Publications of Results:
Responsible Party: Suresh T. Chari, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03731637     History of Changes
Other Study ID Numbers: 17-011305
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Suresh T. Chari, M.D., Mayo Clinic:
New Onset Diabetes
Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases