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Clinical Trial NCT02009514 for End-Stage Kidney Disease, Type 2 Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Tampere University HospitalGlucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients Phase 4 10
Clinical Trial NCT02009514 was designed to study Treatment for End-Stage Kidney Disease, Type 2 Diabetes Mellitus. This was a Phase 4 interventional study that is now completed. The study started on 1 October 2002, with plans to enroll 10 participants. Led by Tampere University Hospital, the expected completion date was 1 March 2004. The latest data from ClinicalTrials.gov was last updated on 22 January 2020.
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.
Official Title
Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
Conditions
End-Stage Kidney DiseaseType 2 Diabetes MellitusOther Study IDs
- R02058M
NCT ID Number
Start Date (Actual)
2002-10
Last Update Posted
2020-01-22
Completion Date (Estimated)
2004-03
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Hemodialysis
Continuous glucose monitoring
Hypoglycemia
Hyperglycemia
Continuous glucose monitoring
Hypoglycemia
Hyperglycemia
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | Glucose-containing compared to glucose-free hemodialysate Comparison of effects on glucose variation |
Primary Outcome Measures
Secondary 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 |
| 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- type 2 diabetic patient
- undergoing stable intermittent thrice weekly hemodialysis for at least one month
- None
Tampere University Hospital109 active studies to exploreStudy Responsible Party
Pasi I Nevalainen, MD, Principal Investigator, MD, PhD, Tampere University Hospital
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