MedTrace Logo

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

NCT02614170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 328

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Prospective Blood Draw

This is prospective collection blood and urine study. This is not a treatment trial or device trial.

Sponsors & Collaborators

  • Fujirebio Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Diana Dickson · Fujirebio Diagnostics, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02614170 on ClinicalTrials.gov