DiabetesNCT02614170
A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals
An observational study of Diabetes, run by Fujirebio Diagnostics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Prospective Blood Draw
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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%)
Show all 17Show fewer
- 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.
- Hemolytic blood specimen
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Fundamental Research LLC
Gulf Shores, Alabama, 36542
About this study
The study objectives are described below:
- 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.
- 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.
- 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.
Read the 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
- Being tested
- Prospective Blood Draw
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Blood DrawOther
This is prospective collection blood and urine study. This is not a treatment trial or device trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure C-peptide and Insulin in Healthy Individuals
250 healthy subjects
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Dickson, Study director, Fujirebio Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614170
- Sponsor's protocol ID
- FDI-115
- Status last verified
- Nov 2015
- First submitted
- 5 Nov 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02614170
- Acronym / sponsor ID
- FDI-115
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are described below:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Blood DrawThis is prospective collection blood and urine study. This is not a treatment trial or device trial. | Other | – |
Primary outcome
Measure C-peptide and Insulin in Healthy Individuals
Time frame: 10 months
250 healthy subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Dickson study director
Fujirebio Diagnostics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Fujirebio Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure C-peptide and Insulin in Healthy Individuals (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.