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A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort
Trial ID: NCT03731637
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).
A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
- Subject is able and willing to provide informed consent and sign an informed consent
- Subject must sign an authorization for the release of their protected health
- 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),
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
- Subject or authorized representative must be willing to complete a detailed
- 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.