N/A
N=34
Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)
Diabetes Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01359904 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Hemoglobin A1c Levels — 7.1; 7.1 percent — p=0.67
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Dialysate bath (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c Levels |
7.1; 7.1 | 0.67 |
| SECONDARY Episodes of Hypoglycemia |
2; 10 | 0.027 sig |
| 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. |
0.3; -0.1 | 0.20 |
| SECONDARY 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 |
4; 3 | 0.32 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01359904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.