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Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00438503
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : September 15, 2015
Sponsor:
Information provided by:
Regional Hospital Holstebro

Tracking Information
First Submitted Date  ICMJE February 20, 2007
First Posted Date  ICMJE February 22, 2007
Last Update Posted Date September 15, 2015
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Relationship between changes in blood pressure and and changes in hormones
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
Relationsship between changes in blood pressure and and changes in hormones
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose in Dialysis Water in Diabetics With Chronic Renal Failure
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Failure, Chronic
  • Diabetic Nephropathies
Intervention  ICMJE Procedure: Procedure
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2007)
18
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00438503
Other Study ID Numbers  ICMJE MED.RES.2007.02.EBP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Regional Hospital Holstebro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erling B Pedersen, Professor Regional Hospital Holstebro
PRS Account Regional Hospital Holstebro
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP