A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort
Where in United States
- Columbus · The Ohio State University -Wexner Medical CenterUnknown status
- Detroit · Henry Ford Health SystemUnknown status
- Gainesville · University of FloridaUnknown status
- Houston · Baylor College of MedicineUnknown status
- Indianapolis · Univeristy Hospital, Indiana University HealthUnknown status
- Los Angeles · Cedars-Sinai Medical CenterUnknown status
- Los Angeles · Greater Los Angeles Veterans Affairs Medical CenterUnknown status
- Los Angeles · Kaiser Permanente Southern CaliforniaUnknown status
- Marshfield · Marshfield Clinic Health SystemUnknown status
- New Orleans · Ochsner Medical CenterUnknown status
- Oakland · Kaiser Permanente Northern CaliforniaUnknown status
- Orlando · Advent Health Translational Research InstituteUnknown status
- Palo Alto · Stanford University Medical CenterUnknown status
- Pittsburgh · University of Pittsburgh Medical CenterUnknown status
- Rochester · Mayo ClinicUnknown status
- Spartanburg · Gibbs Cancer Center & Research InstituteUnknown status
- Urbana · Carle Foundation HospitalUnknown status
- Ypsilanti · Trinity Health Ann Arbor HospitalUnknown status
The registry text, word for word
A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).
Inclusion: 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; (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR; 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; 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: 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; 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; 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.