Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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:
    

Intervention name(s): High Dialysate bath
Intervention type(s): Other
Intervention description(s): The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dialysate glucose; glycemic control; hypoglycemic episodes