Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009514
• Other study ID #: R02058M
• Status: Completed
• Phase: Phase 4
• Start date: October 2002
• Est. completion date: March 2004

Study information

• Verified date: January 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type 2 diabetic patient

• undergoing stable intermittent thrice weekly hemodialysis for at least one month

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Type 2 Diabetes Mellitus

Intervention

Other:
• Glucose-containing compared to glucose-free hemodialysate
Comparison of effects on glucose variation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean glucose	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.	In the end of a two-week period
Other	Mean glucose during specified time intervals	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.	In the end of a two-week period
Other	Glucose above 10.0 mmol/l	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.	In the end of a two-week period
Other	Glucose above 10.0 mmol/l during specified time intervals	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.	In the end of a two-week period
Other	Standard deviation of glucose	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.	In the end of a two-week period
Other	Standard deviation of glucose during specified time intervals	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.	In the end of a two-week period
Primary	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.	In the end of a two week period
Secondary	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.	In the end of a two-week period