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

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ClinicalTrials.gov Identifier: NCT03731637
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : August 5, 2021
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

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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: Omer Mushtaq 206-667-2808 omushtaq@fredhutch.org
Contact: Jackie Dahlgren 206-667-4170 jdahlgre@fredhutch.org

Locations
Show Show 19 study locations
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: August 5, 2021
Last Verified: August 2021
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