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NCT01204216 · ClinicalTrials.gov registry record · NA
Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c
A NA study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01204216: Clinical Trial NA study, sponsored by VA Office of Research and Development.
NCT01204216 is a NA study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01204216, a NA study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
Prevention of complications in veterans with diabetes depends heavily on assessment of blood glucose and HbA1c. The HbA1c is a blood test that measures the exposure of hemoglobin (Hb) to a person's average blood glucose over the lifespan of a red blood cell (RBC). The test is heavily relied upon as a measure of blood glucose control. It is normally assumed that all people (those with and without diabetes) have a narrow range of red blood cell survival. It has been recently shown that this is not a valid assumption. A more precise test of red blood cell survival, using a biotin label method, demonstrated a substantial difference of red blood cell survival among otherwise normal people. There is sufficient difference in red blood cell survival to alter the estimate of glycemic control from the HbA1c test by as much as 30 per cent. This introduces concern that HbA1c values do not mean the same thing in a significant number of people. Although the evidence is clear that there is variation in RBC survival among people, attributing this variation to differences between individuals depends on answering several simple questions which surprisingly remain unanswered: whether RBC survival is stable over time within an individual and whether blood glucose control affects its stability. Therefore, the goal of the proposed studies is to define these characteristics.
Interventions
- BIOLOGICAL re-infusion of biotin labeled cells
- BIOLOGICAL Re-infusion of biotin labeled cells
- BEHAVIORAL Diabetes education/diabetes medication adjustment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-09-01 |
| Est. Completion | 2016-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01204216
The ClinicalTrials.gov registry entry for NCT01204216 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which re-infusion of biotin labeled cells is the first listed.
NCT01204216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01204216 about?
NCT01204216 is a clinical study titled "Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c". Prevention of complications in veterans with diabetes depends heavily on assessment of blood glucose and HbA1c. The HbA1c is a blood test that measures the exposure of hemoglobin (Hb) to a person's average blood glucose over the lifespan of a red blood cell (RBC). The test is heavily relied upon as ...
What is the current status of trial NCT01204216?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2010-09-01. Estimated completion is 2016-09-01.
What interventions are being tested in trial NCT01204216?
The interventions under investigation include: re-infusion of biotin labeled cells (BIOLOGICAL), Re-infusion of biotin labeled cells (BIOLOGICAL), Diabetes education/diabetes medication adjustment (BEHAVIORAL).
Who is sponsoring clinical trial NCT01204216?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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