Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients
Verified date | May 2015 |
Source | Melbourne Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
Dialysis patients suffer from many problems with blood vessels and this is even more so for
patients with the added complication of diabetes. Diabetics have a number of reasons for
vascular disease and one of the new areas of research is looking at the cells that line the
blood vessels, called endothelial cells. It is thought that the number of red blood cells in
the blood (haemoglobin concentration) affects the function of these cells. There is very
little information available on what haemoglobin level is best for dialysis patients. As
diabetics account for almost 40% of dialysis patients worldwide it is important to
understand the effect different haemoglobin levels will have on the blood vessels.
Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels
are affected by different haemoglobin concentrations [Hb] in dialysis patients.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Aged 18-80 years 2. Patients receiving either conventional haemodialysis 3-4 x week, for a duration of > 6 months or peritoneal dialysis for a duration >6 months 3. Stable dialysis access for at least 3 months (Permcath / PTFE / AVF) 4. On erythropoietin and iron therapy, with stable [Hb] x 2 months (105 - 135g/L) Exclusion Criteria: 1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study 2. Patients with dysrhythmias 3. Pre dialysis SBP> 180 mmHg on > 2 times within a 2 week period 4. Between dialysis weight gain > 5% of body weight (if evident > 2 times/ 2 week period) 5. Soft tissue ulcers 6. Non traumatic amputations 7. Unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion 8. Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery) 9. Dementia 10. Clinical inability to comply with testing 11. Malignancy (active / under treatment) 12. Known hypo-responsiveness to ERT (>200U/kg/wk) 13. Evidence of chronic gastrointestinal bleeding 14. Inadequate dialysis (PRU < 65% or KT/V < 1.2) 15. Participation in investigational study within last 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | The Royal Melbourne Hospital | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Melbourne Health |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pulse wave velocity at the three different haemoglobin levels |
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