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Completed

NCT Number: NCT02009514

Glucose Containing and Glucose Free Hemodialysate 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.

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Key information

Conditions

End-stage Kidney Disease Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Mellitus Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Glucose-containing compared to glucose-free hemodialysate

Other

Comparison of effects on glucose variation

Other names: Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207

Primary outcomes

  1. Glucose below 4.0 mmol/l

    Time frame: 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 outcomes

  1. Glucose below 4.0 mmol/l during specified time intervals

    Time frame: 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.

Other outcomes

  1. Mean glucose

    Time frame: In the end of a two-week period

    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.

  2. Mean glucose during specified time intervals

    Time frame: In the end of a two-week period

    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.

  3. Glucose above 10.0 mmol/l

    Time frame: In the end of a two-week period

    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.

  4. Glucose above 10.0 mmol/l during specified time intervals

    Time frame: In the end of a two-week period

    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.

  5. Standard deviation of glucose

    Time frame: In the end of a two-week period

    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.

  6. Standard deviation of glucose during specified time intervals

    Time frame: In the end of a two-week period

    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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Dec 12, 2013
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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