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Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

Primary Purpose

Renal Failure, Chronic, Diabetic Nephropathies

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Procedure
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure, Chronic focused on measuring Hemodialysis, diabetes mellitus,, Chronic renal failure, dialysis ,

Eligibility Criteria

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

Inclusion Criteria:

  1. Age > 18 years,
  2. Both men and women,
  3. Dialysis treatment for at least three month due to diabetic nephropathy

Exclusion Criteria:

  1. Heart failure,
  2. Lung insufficiency,
  3. Chronic liver disease,
  4. Malignant disease,
  5. Nephrotic syndrome,
  6. Lack of compliance,
  7. Unwillingness to participate

Sites / Locations

  • Holstebro Hospital

Outcomes

Primary Outcome Measures

Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma

Secondary Outcome Measures

Relationship between changes in blood pressure and and changes in hormones

Full Information

First Posted
February 20, 2007
Last Updated
September 14, 2015
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT00438503
Brief Title
Glucose in Dialysis Water in Diabetics With Chronic Renal Failure
Official Title
Effect of Glucose in Dialysis Water in Diabetics With Chronic Renal Failure on Blood Pressure, Pulse Rate, Plasma Glucose, Plasma Concentrations of Insulin, Growth Hormone, Renin, Angiotensin II, Endothelin and Body Temperature
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones
Detailed Description
The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic, Diabetic Nephropathies
Keywords
Hemodialysis, diabetes mellitus,, Chronic renal failure, dialysis ,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Procedure
Primary Outcome Measure Information:
Title
Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma
Secondary Outcome Measure Information:
Title
Relationship between changes in blood pressure and and changes in hormones

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years, Both men and women, Dialysis treatment for at least three month due to diabetic nephropathy Exclusion Criteria: Heart failure, Lung insufficiency, Chronic liver disease, Malignant disease, Nephrotic syndrome, Lack of compliance, Unwillingness to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, Professor
Organizational Affiliation
Regional Hospital Holstebro
Official's Role
Study Chair
Facility Information:
Facility Name
Holstebro Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

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Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

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