Trial Outcomes & Findings for Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c (NCT NCT01204216)
NCT ID: NCT01204216
Last Updated: 2023-05-31
Results Overview
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 one year apart.
TERMINATED
NA
3 participants
Baseline and 8 months later
2023-05-31
Participant Flow
Protocol interrupted due to IND closure, precluding completion of the originally described protocol.
Participant milestones
| Measure |
Aim 1
Subjects in this arm will be 10 people without diabetes as well as 10 people with diabetes and stable glycemic control. Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
re-infusion of biotin labeled cells: Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 months.
|
Aim 2
10 additional subjects with diabetes in poor glycemic control will be studied initially and then again in improved glycemic control after at least 8 months (with up to 5 additional subjects entered as needed to ensure 10 completed paired studies) to assess the potential role of MRBC variation in the discordances seen between HbA1c and blood glucose testing. Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
Re-infusion of biotin labeled cells: Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 months.
Diabetes education/diabetes medication adjustment: Between the initial 3-4 month trial period and the second infusion of biotin labeled cells approximately 8 months later, subjects will receive diabetes education from a CDE. In addition, if needed, diabetes medications may be adjusted by the study endocrinologist to improve subject's glycemic control.
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|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c
Baseline characteristics by cohort
| Measure |
Aim 1
n=3 Participants
Subjects in this arm will be 10 people without diabetes as well as 10 people with diabetes and stable glycemic control. Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
re-infusion of biotin labeled cells: Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 months.
|
Aim 2
10 additional subjects with diabetes in poor glycemic control will be studied initially and then again in improved glycemic control after at least 8 months (with up to 5 additional subjects entered as needed to ensure 10 completed paired studies) to assess the potential role of MRBC variation in the discordances seen between HbA1c and blood glucose testing. Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
Re-infusion of biotin labeled cells: Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (\< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 months.
Diabetes education/diabetes medication adjustment: Between the initial 3-4 month trial period and the second infusion of biotin labeled cells approximately 8 months later, subjects will receive diabetes education from a CDE. In addition, if needed, diabetes medications may be adjusted by the study endocrinologist to improve subject's glycemic control.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 months laterPopulation: Protocol interrupted due to IND termination. The data necessary to conduct analysis was not collected.
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 one year apart.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 months laterPopulation: Protocol interrupted due to IND termination. The data necessary to conduct analysis was not collected.
Up to 15 subjects participating in Aim 2 will be studied initially in poor glycemic control, while their second biotin/glucose monitoring study will be performed at least 8 months later after achieving stable glycemic control. If RBC survival varies, and in particular if it varies with glycemic control, then the relationship between HbA1c and MBG will change. Several studies have reported that HbA1c rises linearly with MBG until there is the appearance of a plateau suggesting a saturation maximum.
Outcome measures
Outcome data not reported
Adverse Events
Aim 1
Aim 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert M Cohen, MD, Physician,
Research Service, Cincinnati VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place