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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sameena Iqbal, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01359904
First received: May 23, 2011
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
Other: High Dialysate bath
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359904

Contacts
Contact: Jeffrey How, MD 5149341934 ext 44034 jeffrey.how2@mail.mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Sameena Iqbal, MD    5149341934 ext 44034    sameena.iqbal@mcgill.ca   
Principal Investigator: Sameena Iqbal, MD         
Sub-Investigator: Murray Vasilevsky, MD         
Sponsors and Collaborators
McGill University Health Center
  More Information

No publications provided

Responsible Party: Sameena Iqbal, Associate Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01359904     History of Changes
Other Study ID Numbers: 10-361 GEN
Study First Received: May 23, 2011
Last Updated: October 24, 2012
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 20, 2014