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Glycaemic Control in End-Stage Kidney Disease

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000146099
Enrollment
52
Registered
2010-02-12
Start date
2009-09-16
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 mo

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.

Sponsors

University of Otago
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026