A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Trial ID or NCT#

NCT03731637

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * All glycemic parameters must be measured in an outpatient setting
    1. A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR
    2. B. Any (2) PDMs present on consecutive or simultaneous testing:
  3. * 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
    1. C. Any (1) PDM present followed by an anti-diabetes medication
  4. * 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:
  1. * Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C
  2. * 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).
  3. * 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.
  4. * 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.
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Investigator(s)

Walter Park
Walter Park
Gastroenterologist, Pancreas specialist, Gastrointestinal specialist, Pancreatologist
Associate Professor of Medicine (Gastroenterology and Hepatology)
Bryant Lin
Bryant Lin
Internal medicine doctor
Clinical Professor, Medicine - Primary Care and Population Health

Contact us to find out if this trial is right for you.

Contact

Walter Park, MD
650-723-4102

View on ClinicalTrials.gov