Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Impaired Fasting Glucose, Prediabetes

In brief

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.

Key facts

Study ID

NCT01204216

Run by

VA Office of Research and Development

People needed

3

Starts

2010-09-01

Expected to finish

2016-09-01

Last updated by the study team

2023-05-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects will be between ages 18 and 85 for Aim 1 and between 18 and 80 years for Aim 2 and non-pregnant
• Subjects with both types 1 and 2 diabetes
• Subjects without diabetes (as determined by an OGTT test at screening)
• veterans receiving care at VAMC will be given preference but open to both veterans and non-veterans.

You may not qualify if…

• known hemoglobinopathy or RBC disorder
• positive pregnancy test (in women of child-bearing potential or are breast feeding or planning pregnancy during the course of the study;
• baseline serum creatinine >1.5 mg/dl
• CBC outside the normal range
• history of GI blood loss or coagulopathy
• urine microalbumin >100 mcg/mg creatinine (spot collection);
• transaminases >3 X the upper limit of normal
• presence of serum antibodies to biotinylated proteins (which could interfere with the biotin RBC labeling protocol)
• greater than or equal to NYHA stage 3 heart failure;
• active infection;
• known rheumatologic disease
• uncontrolled hypo-or hyperthyroidism or an underlying illness known to be associated with either body wasting or changes in serum proteins
• plans to move out of the area within the time frame of the Aim for which they are recruited
• unwillingness to perform self monitoring of blood glucose

Where it is running

• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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