A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort


I'm Interested

Trial ID: NCT03731637


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

Official Title

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

Stanford Investigator(s)

Bryant Lin
Bryant Lin

Clinical Professor, Medicine - Primary Care and Population Health


Inclusion Criteria:

   - 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
   months post-enrollment.

   - Subject or authorized representative must be willing to complete a detailed

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.


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Walter Park, MD