Diabetes Type 2NCT01359904
Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)
A study testing High Dialysate bath in people with Diabetes Type 2, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- High Dialysate bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes mellitus
- on chronic hemodialysis (for more than 3 months)
- age > 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Glucose Concentration in the Dialysate Bath on Glycemic Control Among Hemodialysis Patients With Type 2 Diabetes Mellitus
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.
Read more
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.
Read the detailed description
- Study Design: Randomized-controlled study of all type 2 DM patients in dialysis to assess the effect of two different dialysate glucose concentrations, standard 5.5 mmol/L and high 10 mmol/L. The study period will be 20 weeks-4 weeks for recruitment, 12 weeks for the intervention and 4 weeks of data collection and analysis.
- Study Population: All patients with diabetes type 2 in the Montreal General Hospital hemodialysis unit, will be identified by the Head nurses of dialysis units. The following patients will be excluded: anticipated to be transplanted within 6 months, expected death due to malignancy or severe infection within 6 months, uncontrolled blood sugars above 20mmol/l and unable to give consent due to neurologic reasons. Once the head nurse identifies the subject, the potential subject will be approached by the research assistant with a consent form. All patients will be consented by the research assistant through a written consent form. Then the subject will be randomly assigned to the standard or high glucose dialysate groups.
- Methods (i) Baseline Data collection for the standard or high glucose dialysate groups
The following demographic data will be noted: age, gender, duration of diabetes, duration of dialysis, comorbidity using Charlson Comorbidity index, vascular access type (arteriovenous fistula or permanent catheter) and cause of renal failure. The routine previous months' hemodialysis laboratory tests will be recorded such as complete blood count, serum electrolytes, serum glucose, calcium ionized or total, phosphate, parathyroid hormone levels, iron saturation, C reactive protein, ferritin, lipids and serum albumin. No additional blood tests will be taken. HbA1c values are taken every three months, therefore the intervention will be introduced after the HbA1c values have been taken within the month for the subject. No additional blood tests will be taken.
Blood pressure stability during the dialysis treatment will also be recorded defined as the differences in the pre and post mean arterial blood pressure will be documented in the last three dialysis treatments and their mean will be taken for each subject.
(ii) Intervention
After randomization, the subjects randomized to the high glucose group will be flagged in the hemodialysis orders, which on all electronic under the Nephrocare program. Similarly the standard glucose solution will also be flagged in the orders for the subjects randomized to that group.
(iii) Data collection during the Study
Both study groups will have a routine glucometer blood sugar test during the last hour of dialysis. The number of intradialytic asymptomatic and symptomatic hypoglycemic episodes will be recorded for each subject. Outcomes at the end of the 12 weeks of intervention: All subjects will have the following recorded:
- Routine monthly blood work and the Hemoglobin A1c values
- Number of episodes of serum glucose less than or equal to 3 mmol/L using the glucometer during dialysis treatments
- Blood pressure stability during dialysis (mmHg)
- Number of infection events during the 12 weeks will defined according to the Public Health Agency of Canada as stated below:
- Conditions
- Diabetes Type 2
- Being tested
- High Dialysate bath
- Keywords
- dialysate glucose, glycemic control, hypoglycemic episodes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dialysate bathOther
The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.
| Study group | Role | What they receive |
|---|---|---|
| high dialysate bath | Active comparator | additive is put in the dialysate to increase the concentration of glucose to 10mmol/l Receives: Other: High Dialysate bath |
| Standard dialysate glucose concentration | No intervention | Standard 5.5 mmol/L dialysate glucose concentration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c Levels
post intervention hemoglobin A1c levels
Measured: 3 months
Secondary outcomes (3)
Episodes of Hypoglycemia
record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer
Measured: 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.
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.
Measured: 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
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameena Iqbal, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sameena Iqbal, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359904
- Sponsor's protocol ID
- 10-361 GEN
- Status last verified
- Feb 2017
- First submitted
- 23 May 2011
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucose Concentration in the Dialysate Bath on Glycemic Control Among Hemodialysis Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01359904
- Acronym / sponsor ID
- 10-361 GEN
- Conditions
- Diabetes Type 2
- Keywords
- dialysate glucose, glycemic control, hypoglycemic episodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 28 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study Design: Randomized-controlled study of all type 2 DM patients in dialysis to assess the effect of two different dialysate glucose concentrations, standard 5.5 mmol/L and high 10 mmol/L. The study period will be 20 weeks-4 weeks for recruitment, 12 weeks for the intervention and 4 weeks of data collection and analysis.
- Study Population: All patients with diabetes type 2 in the Montreal General Hospital hemodialysis unit, will be identified by the Head nurses of dialysis units. The following patients will be excluded: anticipated to be transplanted within 6 months, expected death due to malignancy or severe infection within 6 months, uncontrolled blood sugars above 20mmol/l and unable to give consent due to neurologic reasons. Once the head nurse identifies the subject, the potential subject will be approached by the research assistant with a consent form. All patients will be consented by the research assistant through a written consent form. Then the subject will be randomly assigned to the standard or high glucose dialysate groups.
- Methods (i) Baseline Data collection for the standard or high glucose dialysate groups
The following demographic data will be noted: age, gender, duration of diabetes, duration of dialysis, comorbidity using Charlson Comorbidity index, vascular access type (arteriovenous fistula or permanent catheter) and cause of renal failure. The routine previous months' hemodialysis laboratory tests will be recorded such as complete blood count, serum electrolytes, serum glucose, calcium ionized or total, phosphate, parathyroid hormone levels, iron saturation, C reactive protein, ferritin, lipids and serum albumin. No additional blood tests will be taken. HbA1c values are taken every three months, therefore the intervention will be introduced after the HbA1c values have been taken within the month for the subject. No additional blood tests will be taken.
Blood pressure stability during the dialysis treatment will also be recorded defined as the differences in the pre and post mean arterial blood pressure will be documented in the last three dialysis treatments and their mean will be taken for each subject.
(ii) Intervention
After randomization, the subjects randomized to the high glucose group will be flagged in the hemodialysis orders, which on all electronic under the Nephrocare program. Similarly the standard glucose solution will also be flagged in the orders for the subjects randomized to that group.
(iii) Data collection during the Study
Both study groups will have a routine glucometer blood sugar test during the last hour of dialysis. The number of intradialytic asymptomatic and symptomatic hypoglycemic episodes will be recorded for each subject. Outcomes at the end of the 12 weeks of intervention: All subjects will have the following recorded:
- Routine monthly blood work and the Hemoglobin A1c values
- Number of episodes of serum glucose less than or equal to 3 mmol/L using the glucometer during dialysis treatments
- Blood pressure stability during dialysis (mmHg)
- Number of infection events during the 12 weeks will defined according to the Public Health Agency of Canada as stated below:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dialysate bath | Active comparator | Other: High Dialysate bathadditive is put in the dialysate to increase the concentration of glucose to 10mmol/l |
| Standard dialysate glucose concentration | No intervention | –Standard 5.5 mmol/L dialysate glucose concentration. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of type 2 diabetes mellitus
- on chronic hemodialysis (for more than 3 months)
- age > 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dialysate bathThe dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution. | Other | high dialysate bath |
Primary outcome
Hemoglobin A1c Levels
Time frame: 3 months
post intervention hemoglobin A1c levels
3 secondary outcomes
Episodes of Hypoglycemia
Time frame: 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.
Time frame: 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
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameena Iqbal, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dialysate bath in people with Diabetes Type 2, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c Levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.