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

NCT02614170 | Completed

• 1 other identifier: FDI-115
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

The study objectives are described below:

1. 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. 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. 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• Measure C-peptide and Insulin in Healthy Individuals

  250 healthy subjects

  10 months

Interventions

Prospective Blood Draw OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 250 subjects will be enrolled in this study. Healthy women and men greater than or equal to 18 years of age having donated a single blood draw, a random urine specimen, and a 24-hour urine collection specimen will be eligible. Each site will evaluate and select patients for enrollment using the inclusion and exclusion criteria listed below. Study subjects should be selected from all available patients at the site. Each patient may be entered into the study only once.

You may qualify if:

• Males and females, age ≥ 18 years
• Fasting for 12 hours prior to blood draw and random urine collection
• Able to understand and willing to provide informed consent
• Normal HbA1c (e.g. less than 5.7%) and glucose (e.g. less than 100 mg/dL) levels

You may not qualify if:

• Males and females, age \<18 years
• Has a current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, would deem the subject unhealthy and therefore, ineligible.
• Has a history of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, is unstable at the time of enrollment.
• Current diagnosis or prior history of any type of diabetes including gestational diabetes.
• Currently taking or history of insulin therapy for any disease.
• Elevated HbA1c level (e.g. greater than 5.7%)
• Elevated glucose level (e.g. greater than or equal to 100 mg/dL)
• Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
• History of seizures
• Diagnosed with an infectious disease including any sexually transmitted diseases.
• Diagnosed with HIV/AIDS or ever tested positive for HIV.
• History of hepatitis
• Subject that has had sexual contact with a person who has hepatitis within the last 12 months.
• Pregnancy or lactation
• Non-fasting for 12 hours prior to blood and random urine collection.

Sponsors & Collaborators

• Fujirebio Diagnostics, Inc.: lead

Study Sites (1)

Fundamental Research LLC

Gulf Shores, Alabama, 36542, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Random Urine and 24 hour Urine

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Diana Dickson

  Fujirebio Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 25, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2015-11

Locations

US (1)