Interactive Studies of Endstage Diabetic Dialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients

Conditions
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Diabetes

Intervention / Treatment
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* Procedure: High Hemoglobin Concentration
* Procedure: Low Hemoglobin Concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetics and non-diabetics on hemodialysis On erythropoietin and iron On a statin Exclusion Criteria: Uncontrolled blood pressure (BP) Ulcers Amputations Unstable cardiac function Malignancy Planned operations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: High Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.|
|Procedure: Low Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test |  | 8-12 months per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires |  | 8-12 months per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Reactivity, Anemia Correction Therapy, Hemodialysis patients, Diabetic and non-diabetic patients, Diabetes in Hemodialysis patients