Diabetes Clinical Trial
Official title:
Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients
The purpose of this study is to document relevant and related clinical changes associated
with different hemoglobin concentrations in diabetic hemodialysis patients.
Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin
concentrations in diabetic hemodialysis patients.
Vascular disease is an important cause of morbidity and mortality in patients with chronic
kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and
multiple reasons for vascular disease, and there is accumulating evidence of associated poor
endothelial cell function, particularly in those with kidney disease. One important
mechanism through which this might occur relates to changes in shear rate and stress
resulting from different viscosity levels. Such fluctuations are increasingly recognized to
affect endothelial cell function and hence vessel-wall adaptability in both the short and
long term.
Little is known of the consequence of different shear effects on endothelial cell function
at various hemoglobin levels in kidney disease. There is some evidence to suggest however
that, in the presence of micro-vascular disease, a relative anemia, with associated lower
viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.
Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing
component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for
anemia therapy, and the impact of different target levels of hemoglobin on vascular wall
function is imperative.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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