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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). 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.
Primary Outcome
The investigators will determine MRBC and MBG (by both 7 point profile and continuous glucose monitoring), twice in 10 subjects without diabetes and in 10 subjects with diabetes at stable glycemic control. Since the time course study for following the disappearance of re-infused labeled RBCs is approximately 4 months, performing the biotin labeling of the cells for the second study at least 8 months after completion of sampling for the first, effectively samples MRBC at two time points at least
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 |
Why NCT01204216 stopped before completion
NCT01204216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which re-infusion of biotin labeled cells is the first listed.
NCT01204216 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01204216's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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