Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359904
Recruitment Status : Completed
First Posted : May 25, 2011
Results First Posted : November 28, 2016
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Sameena Iqbal, McGill University Health Center

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Other: High Dialysate bath Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: no masking
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
Study Start Date : May 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Hemoglobin A1c Levels [ Time Frame: 3 months ]
    post intervention hemoglobin A1c levels

Secondary Outcome Measures :
  1. Episodes of Hypoglycemia [ Time Frame: 3 months ]
    record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer

  2. 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 ]
    Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.

  3. 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 [ Time Frame: 3 months ]
    In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359904

Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Sameena Iqbal, MD Associate Professor

Responsible Party: Sameena Iqbal, Associate Professor, McGill University Health Center Identifier: NCT01359904     History of Changes
Other Study ID Numbers: 10-361 GEN
First Posted: May 25, 2011    Key Record Dates
Results First Posted: November 28, 2016
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sameena Iqbal, McGill University Health Center:
dialysate glucose
glycemic control
hypoglycemic episodes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dialysis Solutions
Pharmaceutical Solutions