Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; End-Stage Kidney Disease

• Registration Number: NCT02009514
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-02
• Study Completion: 2004-03
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.