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

NCT01359904 | Completed Results

• 1 other identifier: 10-361 GEN
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 2

Keywords

dialysate glucose; glycemic control; hypoglycemic episodes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c Levels

  post intervention hemoglobin A1c levels

  3 months

Secondary Outcomes (3)

• Episodes of Hypoglycemia

  3 months

• 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.

  3 months

• 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

  3 months

Study Arms (2)

high dialysate bath

ACTIVE COMPARATOR

additive is put in the dialysate to increase the concentration of glucose to 10mmol/l

Other: High Dialysate bath

Standard dialysate glucose concentration

NO INTERVENTION

Standard 5.5 mmol/L dialysate glucose concentration.

Interventions

High Dialysate bath OTHER

The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.

high dialysate bath

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of type 2 diabetes mellitus
• on chronic hemodialysis (for more than 3 months)
• age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was only short term.

Results Point of Contact

• Title: Sameena Iqbal
• Organization: MUHC

sameena.iqbal@mcgill.ca

5149341934

Study Officials

• Sameena Iqbal, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 21, 2017
• Results First Posted: November 28, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)