Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

NCT02009514 | Completed Phase 4

• 1 other identifier: R02058M
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End-Stage Kidney Disease; Type 2 Diabetes Mellitus

Keywords

Hemodialysis; Continuous glucose monitoring; Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Glucose below 4.0 mmol/l during specified time intervals

  In the end of a two-week period

Other Outcomes (6)

• Mean glucose

  In the end of a two-week period

• Mean glucose during specified time intervals

  In the end of a two-week period

• Glucose above 10.0 mmol/l

  In the end of a two-week period

Interventions

Glucose-containing compared to glucose-free hemodialysate OTHER

Comparison of effects on glucose variation

Also known as: Glucose-containing dialysate SK-F 219/1, Glucose-free dialysate SK-F 207

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Tampere University Hospital: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus, Type 2; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pasi I Nevalainen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 12, 2013
• Study Start: October 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 22, 2020

Record last verified: 2020-01