Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

• Sponsor: Regional Hospital Holstebro (Other)
• Overall Status: Completed
• CT.gov ID: NCT00438503
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure, Chronic; Diabetic Nephropathies	Procedure: Procedure	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2006
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma []

Secondary Outcome Measures

1. Relationship between changes in blood pressure and and changes in hormones []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holstebro Hospital	Holstebro		Denmark	7500

Sponsors and Collaborators

• Regional Hospital Holstebro

Investigators

• Study Chair: Erling B Pedersen, Professor, Regional Hospital Holstebro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00438503
• Other Study ID Numbers: MED.RES.2007.02.EBP
• First Posted: Feb 22, 2007
• Last Update Posted: Sep 15, 2015
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: Hemodialysis, diabetes mellitus,; Chronic renal failure, dialysis ,
• Additional relevant MeSH terms: Renal Insufficiency; Diabetic Nephropathies; Kidney Failure, Chronic

Study Results

No Results Posted as of Sep 15, 2015