A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Stopped early

Conditions studied: Diabetes, Type2 Diabetes, Diabetes Mellitus

In brief

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

Key facts

Study ID: NCT03731637
Run by: Fred Hutchinson Cancer Center
People needed: 2269
Starts: 2018-10-15
Expected to finish: 2025-03-31
Last updated by the study team: 2025-04-30

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Kaiser Permanente Southern California — Los Angeles, California, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
Greater Los Angeles Veterans Affairs Medical Center — Los Angeles, California, United States
Kaiser Permanente Northern California — Oakland, California, United States
Stanford University Medical Center — Palo Alto, California, United States
University of Florida — Gainesville, Florida, United States
Advent Health Translational Research Institute — Orlando, Florida, United States
Carle Foundation Hospital — Urbana, Illinois, United States
Univeristy Hospital, Indiana University Health — Indianapolis, Indiana, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
Henry Ford Health System — Detroit, Michigan, United States
Trinity Health Ann Arbor Hospital — Ypsilanti, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center & Research Institute — Spartanburg, South Carolina, United States
Baylor College of Medicine — Houston, Texas, United States
Marshfield Clinic Health System — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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