Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02009514

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Kidney Disease Type 2 Diabetes Mellitus	Other: Glucose-containing compared to glucose-free hemodialysate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Glucose below 4.0 mmol/l [In the end of a two week period]
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 [In the end of a two-week period]
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.

Other Outcome Measures

Mean glucose [In the end of a two-week period]
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.
Mean glucose during specified time intervals [In the end of a two-week period]
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.
Glucose above 10.0 mmol/l [In the end of a two-week period]
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.
Glucose above 10.0 mmol/l during specified time intervals [In the end of a two-week period]
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.
Standard deviation of glucose [In the end of a two-week period]
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.
Standard deviation of glucose during specified time intervals [In the end of a two-week period]
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.