Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; End-Stage Kidney Disease
• Intervention / Treatment: Other: Glucose-containing compared to glucose-free hemodialysate

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• type 2 diabetic patient
• undergoing stable intermittent thrice weekly hemodialysis for at least one month

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Pasi I Nevalainen, MD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Hypoglycemia; Hyperglycemia; Hemodialysis; Continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Kidney Diseases; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions; Hemodialysis Solutions
• Other Study ID Numbers: R02058M