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Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

Primary Purpose

End-Stage Kidney Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glucose-containing compared to glucose-free hemodialysate
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 3, 2013
    Last Updated
    January 20, 2020
    Sponsor
    Tampere University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02009514
    Brief Title
    Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
    Official Title
    Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tampere University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End-Stage Kidney Disease, Type 2 Diabetes Mellitus
    Keywords
    Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Glucose-containing compared to glucose-free hemodialysate
    Other Intervention Name(s)
    Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207
    Intervention Description
    Comparison of effects on glucose variation
    Primary Outcome Measure Information:
    Title
    Glucose below 4.0 mmol/l
    Description
    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.
    Time Frame
    In the end of a two week period
    Secondary Outcome Measure Information:
    Title
    Glucose below 4.0 mmol/l during specified time intervals
    Description
    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.
    Time Frame
    In the end of a two-week period
    Other Pre-specified Outcome Measures:
    Title
    Mean glucose
    Description
    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.
    Time Frame
    In the end of a two-week period
    Title
    Mean glucose during specified time intervals
    Description
    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.
    Time Frame
    In the end of a two-week period
    Title
    Glucose above 10.0 mmol/l
    Description
    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.
    Time Frame
    In the end of a two-week period
    Title
    Glucose above 10.0 mmol/l during specified time intervals
    Description
    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.
    Time Frame
    In the end of a two-week period
    Title
    Standard deviation of glucose
    Description
    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.
    Time Frame
    In the end of a two-week period
    Title
    Standard deviation of glucose during specified time intervals
    Description
    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.
    Time Frame
    In the end of a two-week period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: type 2 diabetic patient undergoing stable intermittent thrice weekly hemodialysis for at least one month Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pasi I Nevalainen, MD
    Organizational Affiliation
    Tampere University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

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