Trial Review

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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
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.
Secondary ID [1] 1402 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 256792 0
Chronic kidney disease 256793 0
Condition category
Condition code
Renal and Urogenital 256941 256941 0 0
Kidney disease
Metabolic and Endocrine 256942 256942 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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the subjects are requested to perform a self-monitoring 7- point glucose profile After 48 hours a blood sample will be withdrawn for measuring levels of HbA1c, glycated albumin and plasma glucose.
Intervention code [1] 255997 0
Early detection / Screening
Intervention code [2] 255998 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 257818 0
the relationship between real-time glucose and HbA1c and glycated albumin in diabetics with end-stage renal disease and diabetics with normal renal function.
Timepoint [1] 257818 0
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.
Secondary outcome [1] 263236 0
Nil
Timepoint [1] 263236 0
Nil

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 2474 0
New Zealand
State/province [1] 2474 0

Funding & Sponsors
Funding source category [1] 256504 0
Charities/Societies/Foundations
Name [1] 256504 0
University of Otago Research Committee
Country [1] 256504 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Great King Street PO Box 913 Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 255814 0
Hospital
Name [1] 255814 0
Dunedin Hospital
Address [1] 255814 0
Great King Street Private Bag Dunedin 9010
Country [1] 255814 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258551 0
Lower South Regional Ethics Committee
Ethics committee address [1] 258551 0
PO Box 5849 Dunedin 9010
Ethics committee country [1] 258551 0
New Zealand
Date submitted for ethics approval [1] 258551 0
Approval date [1] 258551 0
21/08/2009
Ethics approval number [1] 258551 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30826 0
Address 30826 0
Country 30826 0
Phone 30826 0
Fax 30826 0
Email 30826 0
Contact person for public queries
Name 14073 0
Dr Frederiek Vos
Address 14073 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 14073 0
New Zealand
Phone 14073 0
64 3 4740999
Fax 14073 0
64 3 4747641
Email 14073 0
[email protected]
Contact person for scientific queries
Name 5001 0
Dr Frederiek Vos
Address 5001 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 5001 0
New Zealand
Phone 5001 0
64 3 4740999
Fax 5001 0
64 3 4747641
Email 5001 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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