Clinical trial NCT01359904: Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)
Official title: The Effect of Glucose Concentration in the Dialysate Bath on Glycemic Control Among Hemodialysis Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: dialysate glucose
glycemic control
hypoglycemic episodes
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

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.

Objective:

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.

Methods:

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.

Detailed description: 1. Study Design:

   Randomized-controlled study of all type 2 DM patients in dialysis to assess the effect of two different dialysate glucose concentrations, standard 5.5 mmol/L and high 10 mmol/L. The study period will be 20 weeks-4 weeks for recruitment, 12 weeks for the intervention and 4 weeks of data collection and analysis.
2. Study Population:

   All patients with diabetes type 2 in the Montreal General Hospital hemodialysis unit, will be identified by the Head nurses of dialysis units. The following patients will be excluded: anticipated to be transplanted within 6 months, expected death due to malignancy or severe infection within 6 months, uncontrolled blood sugars above 20mmol/l and unable to give consent due to neurologic reasons.

   Once the head nurse identifies the subject, the potential subject will be approached by the research assistant with a consent form.

   All patients will be consented by the research assistant through a written consent form. Then the subject will be randomly assigned to the standard or high glucose dialysate groups.
3. Methods

(i) Baseline Data collection for the standard or high glucose dialysate groups

The following demographic data will be noted: age, gender, duration of diabetes, duration of dialysis, comorbidity using Charlson Comorbidity index, vascular access type (arteriovenous fistula or permanent catheter) and cause of renal failure. The routine previous months' hemodialysis laboratory tests will be recorded such as complete blood count, serum electrolytes, serum glucose, calcium ionized or total, phosphate, parathyroid hormone levels, iron saturation, C reactive protein, ferritin, lipids and serum albumin. No additional blood tests will be taken. HbA1c values are taken every three months, therefore the intervention will be introduced after the HbA1c values have been taken within the month for the subject. No additional blood tests will be taken.

Blood pressure stability during the dialysis treatment will also be recorded defined as the differences in the pre and post mean arterial blood pressure will be documented in the last three dialysis treatments and their mean will be taken for each subject.

(ii) Intervention

After randomization, the subjects randomized to the high glucose group will be flagged in the hemodialysis orders, which on all electronic under the Nephrocare program. Similarly the standard glucose solution will also be flagged in the orders for the subjects randomized to that group.

(iii) Data collection during the Study

Both study groups will have a routine glucometer blood sugar test during the last hour of dialysis. The number of intradialytic asymptomatic and symptomatic hypoglycemic episodes will be recorded for each subject. Outcomes at the end of the 12 weeks of intervention: All subjects will have the following recorded:

1. Routine monthly blood work and the Hemoglobin A1c values
2. Number of episodes of serum glucose less than or equal to 3 mmol/L using the glucometer during dialysis treatments
3. Blood pressure stability during dialysis (mmHg)
4. Number of infection events during the 12 weeks will defined according to the Public Health Agency of Canada as stated below:

Eligibility criteria: Inclusion Criteria:

* diagnosis of type 2 diabetes mellitus
* on chronic hemodialysis (for more than 3 months)
* age \> 18 years

Exclusion Criteria:

* anticipated to be transplanted within 6 months
* expected death due to malignancy or severe infection within 6 months
* uncontrolled blood sugars above 20mmol/l
* unable to give consent due to neurologic reasons

Primary outcomes:
measure: Hemoglobin A1c Levels
timeFrame: 3 months
Secondary outcomes:
measure: Episodes of Hypoglycemia
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: the Number 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Associate Professor
name: Sameena Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References: