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

Diabetes Type 2 Clinical Trial

Official title:

The Effect of Glucose Concentration in the Dialysate Bath on Glycemic Control Among Hemodialysis Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01359904
• Other study ID #: 10-361 GEN
• Status: Recruiting
• Phase: Phase 3
• First received: May 23, 2011
• Last updated: October 24, 2012
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: McGill University Health Center
• Contact: Jeffrey How, MD
• Phone: 5149341934
• Email: jeffrey.how2[@]mail.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer	3 months	Yes
Secondary	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.	Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value.	3 months	Yes
Secondary	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	In the two groups, we will measure the number of infections vascular related in the study period	3 months	Yes
Secondary	hemoglobin A1c levels	pre and post hemoglobin A1c levels	twelve weeks from allocation	No