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

January 9, 2024 updated by: Ziding Feng, Fred Hutchinson Cancer Center

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

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

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 5 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

Enrollment (Actual)

2270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Southern California
      • Los Angeles, California, United States, 90073
        • Greater Los Angeles Veterans Affairs Medical Center
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California
      • Palo Alto, California, United States, 94605
        • Stanford University Medical Center
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Orlando, Florida, United States, 32804
        • Advent Health Translational Research Institute
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Univeristy Hospital, Indian University Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health Ann Arbor Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Cancer Center & Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects who newly meet criteria for diabetes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Study Chair: Suresh Chari, MD, M.D. Anderson Cancer Center
  • Study Chair: Anirban Maitra, MBBS, M.D. Anderson Cancer Center
  • Study Chair: Bechien Wu, MD, Kaiser Permanente Southern Califorina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-011305
  • U01DK108328 (U.S. NIH Grant/Contract)
  • A211701 (Other Identifier: CTEP Identifier)
  • NCI-2018-01307 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RG1001811 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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