Status:
TERMINATED
Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Cincinnati
Conditions:
Diabetes Mellitus
Impaired Fasting Glucose
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 av...
Detailed Description
The first Specific Aim tests the hypothesis that mean RBC age is stable in subjects without diabetes and in subjects with diabetes at stable glycemic control. The second Specific Aim tests the hypothe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01204216
Start Date
September 1 2010
End Date
September 1 2016
Last Update
May 31 2023
Active Locations (1)
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1
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220