Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)
Recruitment status was Recruiting
Type II diabetes is a disease that affects more than 246 million people worldwide. Most importantly, one of the complications of type II diabetes is kidney damage and this has lead to many patients seeking hemodialysis treatment, a type of kidney replacement therapy. However, during hemodialysis treatment, many patients are greatly at risk for having their blood sugar drop below normal and this can lead to neurological problems. Also, it has been reported that hemodialysis patients who have poorer control of blood glucose levels are at risk to developing heart problems. It has been shown that adding 5.5 mmol/L of glucose in the hemodialysis treatment can reduce the chances of having an abnormal decrease in blood glucose levels. Currently, some institutions use 10 mmol/L of glucose (instead of 5.5 mmol/L) in the hemodialysis treatment, however, there is little documented support to justify for this action.
The investigators are would like to explore the effects of use of 10 mmol/L of glucose in hemodialysis treatment and to determine if it worsens control of blood glucose levels, both during the treatment sessions and over the long term in type II diabetes patients. Also, patients on hemodialysis are prone to infection, so we will also observe if there is any change in infection rate among these patients with increased glucose in the treatment.
The study will consist of 40 patients who will be randomly split into 2 groups. One group will be treated with 5.5 mmol/L glucose in the hemodialysis treatment and the other group will have 10 mmol/L glucose in the treatment. During the hemodialysis treatment, patient blood glucose will be measured at set intervals to check for any acute drops in glucose levels. Also, to assess long-term control of blood glucose levels, each patient will have 2 blood tests, one at the start and another at the end of the experiment. Signs of infection will be checked at the start of each session. Each patient will remain in their group for the duration of the study, which is 12 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Glucose Concentration in the Dialysate Bath on Glycemic Control Among Hemodialysis Patients With Type 2 Diabetes Mellitus|
- To assess if the concentration of glucose in the dialysate solution decreases the number of hypoglycemic episodes in hemodialysis patients with type 2 diabetes mellitus by use of glucometers [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer
- To record the effects of a higher dialysate concentration of glucose on glycemic control of hemodialysis patients with type 2 diabetes mellitus by measuring serum levels of hemoglobin A1c. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value.
- To compare the rate of infections related to vascular access in dialysis among those who receive a higher glucose concentration in the dialysate and those who receive the standard concentration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]In the two groups, we will measure the number of infections vascular related in the study period
- hemoglobin A1c levels [ Time Frame: twelve weeks from allocation ] [ Designated as safety issue: No ]pre and post hemoglobin A1c levels
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: high dialysate bath
additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
Other: High Dialysate bath
The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.
No Intervention: Standard dialysate glucose concentration
Standard 5.5 mmol/L dialysate glucose concentration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359904
|Contact: Jeffrey How, MD||5149341934 ext firstname.lastname@example.org|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Sameena Iqbal, MD 5149341934 ext 44034 email@example.com|
|Principal Investigator: Sameena Iqbal, MD|
|Sub-Investigator: Murray Vasilevsky, MD|