Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
Primary Purpose
End-Stage Kidney Disease, Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glucose-containing compared to glucose-free hemodialysate
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetic patient
- undergoing stable intermittent thrice weekly hemodialysis for at least one month
Exclusion Criteria:
- None
Sites / Locations
Outcomes
Primary Outcome Measures
Glucose below 4.0 mmol/l
In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday.
Secondary Outcome Measures
Glucose below 4.0 mmol/l during specified time intervals
Percentage of hypoglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Full Information
NCT ID
NCT02009514
First Posted
December 3, 2013
Last Updated
January 20, 2020
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02009514
Brief Title
Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
Official Title
Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate differences in glycemia
during the whole hemodialysis day and the whole freeday
during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Kidney Disease, Type 2 Diabetes Mellitus
Keywords
Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Glucose-containing compared to glucose-free hemodialysate
Other Intervention Name(s)
Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207
Intervention Description
Comparison of effects on glucose variation
Primary Outcome Measure Information:
Title
Glucose below 4.0 mmol/l
Description
In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday.
Time Frame
In the end of a two week period
Secondary Outcome Measure Information:
Title
Glucose below 4.0 mmol/l during specified time intervals
Description
Percentage of hypoglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Other Pre-specified Outcome Measures:
Title
Mean glucose
Description
Mean glucose of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Title
Mean glucose during specified time intervals
Description
Mean glucose during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Title
Glucose above 10.0 mmol/l
Description
Percentage of hyperglycemic values of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Title
Glucose above 10.0 mmol/l during specified time intervals
Description
Percentage of hyperglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Title
Standard deviation of glucose
Description
Standard deviation of glucose of continuous glucose monitoring during the whole glucose-containing and glucose-free hemodialysis day is compared to the whole glucose-containing and glucose-free freeday, respectively. Similar comparison is made between the whole glucose-containing and glucose-free hemodialysis day and between the whole glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
Title
Standard deviation of glucose during specified time intervals
Description
Standard deviation of glucose during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday.
Time Frame
In the end of a two-week period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetic patient
undergoing stable intermittent thrice weekly hemodialysis for at least one month
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi I Nevalainen, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
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