Diabetes Clinical Trial
Official title:
A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals
The study objectives are described below:
1. Obtain matched serum, plasma [(K2 EDTA, Sodium Heparin (NaH), Lithium Heparin (LiH)]
and urine specimens collected from a minimum of 50 healthy subjects. Specimens will be
used to determine a reference range for C-peptide and insulin assays, used as an aid in
the assessment of C-peptide and insulin in adults.
2. Obtain serum and urine specimens collected from a minimum of an additional 200 healthy
subjects. Specimens will be used to determine a reference range for C-peptide and
insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.
3. To store any remaining specimens for use in future assay development and to evaluate as
yet undetermined assays for the development of IVDs, including additional C-peptide or
insulin assays.
The primary object of this study is to obtain a series of blood and urine specimens from women and men who are healthy with no history of abnormal blood sugar levels. The specimens will be used to evaluate new C-peptide and insulin assays (tests). Participants are being asked to voluntarily take part in this study because they are a healthy individual without a history of abnormal blood sugar levels. ;
Observational Model: Cohort, Time Perspective: Prospective
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