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Evaluating glucose control before, during and after haemodialysis in patients with diabetes who are using insulin.


- candidate number14175
- NTR NumberNTR3782
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2013
- Secondary IDsNL32332.042.10 CCMO
- Public TitleEvaluating glucose control before, during and after haemodialysis in patients with diabetes who are using insulin.
- Scientific TitleEvaluating the relationship between haemodialysis and glucose control in insulin-treated diabetic patients: A pilot study.
- ACRONYMNA
- hypothesisGlucose 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Hemodialysis, Continuous glucose monitoring
- Inclusion criteria1. Insulin treated diabetes (type 1 or type 2) on haemodialysis;
2. Age =/> 18 years;
3. Male or female.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 23-nov-2010
- planned closingdate31-dec-2013
- Target number of participants20
- InterventionsContinuous 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.
- Primary outcomeMean glucose concentration and area-under-the-curve (AUC) glucose during 24-hour periods, on days with and without haemodialysis.
- Secondary outcome1. 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.
- TimepointsThe observation period of each participant is 5 days, during which CGM takes place.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.N. Kerstens
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.N. Kerstens
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Abbott
- Publications(1) Abe M, Kaizu K, Matsumoto K. Evaluation of the hemodialysis-induced changes in plasma glucose and insulin concentrations in diabetic patients: comparison between the hemodialysis and non-hemodialysis days. Ther Apher Dial 11, 288-295. 2007.
(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.
(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.
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD6-jan-2013 - 20-jan-2013


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