No registrations found.
ID
Source
Brief title
Health condition
diabetes mellitus
haemodialysis
continuous glucose monitoring
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean glucose concentration and area-under-the-curve (AUC) glucose during 24-hour periods, on days with and without haemodialysis.
Secondary outcome
1. Frequency of glucose < 3.5 mmol/L, < 3.0 mmol/L and < 2.5 mmol/L;
2. Frequency and severity of self-reported symptomatic hypoglycaemia;
3. Correlation between day-to-day variations in physical activity and glucose levels;
4. Correlation between day-to-day variations in food intake and glucose levels;
5. Elimination rate of insulin and/or glucose during haemodialysis.
Background summary
Rationale:
Glucose control in diabetic patients with end stage renal disease might be influenced by treatment with haemodialysis, but data on this subject are limited. Haemodialysis could affect glucose control through several mechanisms. It has been suggested that insulin is eliminated directly by the haemodialysis procedure itself. In addition, glucose control during haemodialysis could also be influenced by indirect mechanisms such as changes in food intake and physical activity.
Objective: The main objective is to compare glucose profiles recorded by continuous glucose monitoring (CGM) on days with and without haemodialysis in a group of insulin treated diabetic patients. Secondary objectives are to evaluate the relationship between food intake or physical activity and glucose profiles on days with and without haemodialysis and to examine the pharmacokinetics of insulin during haemodialysis.
Study design:
Short term invasive observational multicenter study.
Study population:
Adult patients (age=/> 18 years) with insulin treated diabetes undergoing regular haemodialysis treatment (n=20).
Main study parameters/endpoints:
Mean glucose concentration and area-under-the-curve (AUC) of glucose during 24-hour periods, frequency and severity of hypoglycaemic episodes, on days with and without haemodialysis.
Methods:
Glucose measurement by continuous glucose monitoring during 5 days. Food intake and hypoglycaemic episodes are recorded by the patients in a structured diary. Physical activity is monitored by means of a pedometer, except in those patients who are immobilised (e.g. leg amputation, paralysis). A subgroup of 10 diabetic patients also participates in a pharmacokinetics study. In these patients, blood samples for determination of glucose and insulin will be drawn before, during (at one hour intervals) and directly after one haemodialysis session simultaneously from the arterial and venous side of the haemodialysis unit. Dialysate will be sampled simultaneously for glucose measurement.
Study objective
Glucose control in diabetic patients with end stage renal disease might be influenced by treatment with haemodialysis, but data on this subject are limited. Haemodialysis could affect glucose control through several mechanisms. It has been suggested that insulin is eliminated directly by the haemodialysis procedure itself. In addition, glucose control during haemodialysis could also be influenced by indirect mechanisms such as changes in food intake and physical activity.
The main objective of this study is to compare glucose profiles recorded by continuous glucose monitoring (CGM) on days with and without haemodialysis in a group of insulin treated diabetic patients. Secondary objectives are to evaluate the relationship between food intake or physical activity and glucose profiles on days with and without haemodialysis and to examine the pharmacokinetics of insulin during haemodialysis.
Study design
The observation period of each participant is 5 days, during which CGM takes place.
Intervention
Continuous glucose monitoring (CGM) will be performed during 5 days in each participant. Participants receive regular daytime haemodialysis 3 times a week and CGM is started at the beginning of the first session of the week.
University Medical Center Groningen
M.N. Kerstens
Groningen
The Netherlands
+31 (0)50 3616161/3518
m.n.kerstens@umcg.nl
University Medical Center Groningen
M.N. Kerstens
Groningen
The Netherlands
+31 (0)50 3616161/3518
m.n.kerstens@umcg.nl
Inclusion criteria
1. Insulin treated diabetes (type 1 or type 2) on haemodialysis;
2. Age =/> 18 years;
3. Male or female.
Exclusion criteria
1. Secondary form of diabetes;
2. Use of oral hypoglycaemic drugs;
3. Use of oral/parental glucocorticoids;
4. Inability to understand written and oral instructions in Dutch and to adhere to study protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3616 |
| NTR-old | NTR3782 |
| CCMO | NL32332.042.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39344 |
Summary results
(2) Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T et al. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care 2009; 32(7):1137-1142.<br>
(3) Riveline JP, Teynie J, Belmouaz S et al. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant 2009; 24(9):2866-2871.