Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

Diabetic Nephropathies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438503
• Other study ID #: MED.RES.2007.02.EBP
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2007
• Last updated: September 14, 2015
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: September 2007
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Failure, Chronic
• Renal Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• Procedure

Locations

Country	Name	City	State
Denmark	Holstebro Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma
Secondary	Relationship between changes in blood pressure and and changes in hormones