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Trial record 49 of 90 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731637
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Ziding Feng, Fred Hutchinson Cancer Research Center

Brief Summary:
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Actual Study Start Date : December 29, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

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



Primary Outcome Measures :
  1. Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and 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 hyperglycemia and diabetes.

  2. Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Subject is able and willing to provide informed consent and sign an informed consent form.
  • Subject must sign an authorization for the release of their protected health information.
  • Subject must be ≥50 and ≤85 years of age at the time of enrollment.
  • Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:

    • All glycemic parameters must be measured in an outpatient setting

A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR

B. Any (2) PDMs present on consecutive or simultaneous testing:

  • Fasting Blood Glucose (FBG) ≥126 mg/dl
  • Hemoglobin A1c (HbA1c) ≥ 6.5%
  • Random Blood Glucose (RBG) ≥200 mg/dl
  • 2h Post Glucose (PG) ≥200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test), OR

C. Any (1) PDM present followed by an anti-diabetes medication

  • Subject must have >1 glycemic parameter measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.
  • Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.
  • Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

  • Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

    • Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
  • Subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

    • Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
  • Subject must not have any past history of pancreatic cancer.
  • Subject must not be on anti-diabetes medications prior to the elevated index lab.
  • Subject must not be on chronic or acute use of steroid medications within 90 days of the elevated index lab.

    • Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
  • Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.
  • In the physician's and/or investigator's judgement, subject does not have any co-morbidities that limit the subject's participation in the study.

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

Locations
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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 Recruiting
Los Angeles, California, United States, 90048
Contact: Stephen Pandol, MD    310-423-6082    stephen.pandol@cshs.org   
Kaiser Permanente Northern California 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 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: Zeb Saeed, MD       zisaeed@iupui.edu   
United States, Michigan
St. Joseph Mercy Health System Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Philip Stella, MD       Philip.stella@stjoeshealth.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gloria Petersen, Ph.D.       Petersen.Gloria@mayo.edu   
United States, Ohio
The Ohio State University Wexner Medical Center 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 Recruiting
Houston, Texas, United States, 77030
Contact: William Fisher, MD    713-798-4321    wfisher@bcm.edu   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Alliance for Clinical Trials in Oncology
Investigators
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Study Chair: Suresh Chari, MD M.D. Anderson Cancer Center
Study Chair: Anirban Maitra, MBBS M.D. Anderson Cancer Center
Additional Information:
Publications of Results:
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Responsible Party: Ziding Feng, Professor, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03731637    
Other Study ID Numbers: 17-011305
U01DK108328 ( U.S. NIH Grant/Contract )
A211701 ( Other Identifier: CTEP Identifier )
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziding Feng, Fred Hutchinson Cancer Research Center:
New Onset Diabetes
Diabetes
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases