NCT02614170

A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 328 (actual)
• Sponsor: Fujirebio Diagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
OTHER	Prospective Blood Draw	This is prospective collection blood and urine study. This is not a treatment trial or device trial.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-25
• Last updated: 2016-08-10

Locations

1 site across 1 country: United States