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Trial registered on ANZCTR
Registration number
ACTRN12610000146099
Ethics application status
Approved
Date submitted
10/02/2010
Date registered
12/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Glycaemic Control in End-Stage Kidney Disease
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Scientific title
Markers of Glycaemic Control: relationship between real-time glucose and glycated haemoglobin (HbA1c) and glycated albumin (GA) in diabetics with end-stage renal disease and diabetics with normal renal function.
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Secondary ID [1]
1402
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Chronic kidney disease
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Condition category
Condition code
Renal and Urogenital
256941
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0
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Kidney disease
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Metabolic and Endocrine
256942
256942
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Real time glucose will be measured by means of continuous glucose monitoring as main indicator of glucose control and compared to levels of glycated haemoglobin (HbA1c) and glycated albumin (GA) in diabetics with end-stage renal disease (ESRD). All participants will be monitored for a period of 48 hours by means of continuous subcutaneous glucose monitoring (CGM). A sensor will be inserted into the subcutaneous tissue of the abdomen and connected to the glucose monitor. During the 48 hours of monitoring the subjects are requested to perform a self-monitoring 7- point glucose profile After 48 hours a blood sample will be withdrawn for measuring levels of HbA1c, glycated albumin and plasma glucose.
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Intervention code [1]
255997
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Early detection / Screening
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Intervention code [2]
255998
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Prevention
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Comparator / control treatment
Real time glucose will be measured by means of continuous glucose monitoring (as described above) as main indicator of glucose control and compared to levels of HbA1c and GA in diabetics with normal renal function.
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Control group
Active
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Outcomes
Primary outcome [1]
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the relationship between real-time glucose and HbA1c and glycated albumin in diabetics with end-stage renal disease and diabetics with normal renal function.
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Assessment method [1]
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Timepoint [1]
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All participants will be monitored for a period of 48 hours by means of continuous subcutaneous glucose monitoring (CGM). During the 48 hours of monitoring the subjects are requested to perform a self-monitoring 7- point glucose profile (finger prick blood sugar monitoring that is standard for diabetics) before and 90 minutes after each meal, and before bedtime. After 48 hours a blood sample will be withdrawn either by venapuncture or from the dialyzer circuit for measuring levels of HbA1c, glycated albumin and plasma glucose.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
All participants:
At least 18 years of age, control patients estimated glomerular filtration rate (eGFR) >60ml/min, stable diabetes mellitus (type 1 and type 2) (no change in medications over the past 2 months)
Participants with end-stage renal disease:
Stable and on dialysis for at least 2 months or predialysis with eGFR <30ml/min, on erythropoietin or iron supplement therapy, haemoglobin within the recommended target range (Hb: 110-130 g/l)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to give informed consent, haemoglobinopathies, hypoalbuminaemia of any cause, anaemia of any cause (except secondary to renal disease), blood transfusion of whole blood or red blood cells within 30 days prior to study entry, chronic liver disease, steroid therapy, current acute illness or malignancy, pregnancy.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
16/09/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2474
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New Zealand
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State/province [1]
2474
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Funding & Sponsors
Funding source category [1]
256504
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Charities/Societies/Foundations
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Name [1]
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University of Otago Research Committee
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Address [1]
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University of Otago PO Box 56. Dunedin 9010
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Country [1]
256504
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
Great King Street PO Box 913 Dunedin 9010
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Country
New Zealand
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Dunedin Hospital
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Address [1]
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Great King Street Private Bag Dunedin 9010
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Country [1]
255814
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258551
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Lower South Regional Ethics Committee
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Ethics committee address [1]
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PO Box 5849 Dunedin 9010
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
258551
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Approval date [1]
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21/08/2009
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Ethics approval number [1]
258551
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Summary
Brief summary
Diabetes mellitus, especially when poorly controlled, can lead to multiple complications of which chronic kidney disease (CKD) is the most common. High glucose binds to haemoglobin (called Glycated haemoglobin or HbA1c) in red blood cells at a constant rate during the life span of the blood cells. The amount of HbA1c is widely accepted as a marker of diabetic control with higher concentrations indicating poorer glycaemic control. In patients with CKD, the production and life span of the red blood cells are reduced, plus erythropoietin treatment increases the proportion of young red blood cells. Thus HbA1c concentrations may not reflect long term glucose exposure in diabetes with CKD and falsely indicate adequate diabetic control. Glycated albumin (GA) may be an attractive alternative in CKD as it reflects glycaemic control, but its production is not altered in renal failure, nor affected by erythropoietin therapy. This study proposes to investigate the accuracy of HbA1c and glycated albumin as markers of diabetic control in end-stage renal disease (ESRD). Real time glucose will be measured by means of continuous glucose monitoring as main indicator of glucose control and compared to levels of HbA1c and GA in diabetics with ESRD and normal renal function.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Frederiek Vos
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Address
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Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
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Country
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New Zealand
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Phone
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64 3 4740999
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Fax
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64 3 4747641
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Frederiek Vos
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Address
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Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
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Country
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New Zealand
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Phone
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64 3 4740999
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Fax
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64 3 4747641
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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