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

Fred Hutchinson Cancer Center (FHCC)

Status: Terminated

Conditions: Diabetes; Type2 Diabetes; Diabetes Mellitus

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03731637

U01DK108328 (U.S. NIH Grant/Contract)

A211701 (Other Identifier)

RG1001811 (Other Identifier)

NCI-2018-01307 (Registry Identifier)

17-011305

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,269 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,269 participants in 1 patient group

New-onset diabetes

Description:

Subjects with biochemically-defined new-onset diabetes