Plain English Summary
Background and study aims
In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. When the kidneys fail, they stop cleaning the blood, leading to the build-up of harmful waste products. Dialysis is a common treatment for kidney disease, where harmful waste products and excess fluid are removed from the body, usually by diverting a patient’s blood through a special filtering machine, which uses a solution called dialysate to draw waste products out of the blood to ‘clean’ it. Advanced glycation end products (AGE) are a family of waste products which are formed by reactions with sugar breakdown products (glucose metabolites). In patients undergoing dialysis treatment, AGE often accumulate, and build up in connective tissues, for example in the collagen of the skin. Some AGE are visible if UV light is shone on them through a device called an AGE-reader (skin autoflourescence). The aim of this study is to compare the skin autoflourescence in dialysis patients when a dialysate containing glucose and one containing no glucose is used.
Who can participate?
Adults who are on long term dialysis treatment at the dialysis unit at Norrlands University Hospital, Umeå, Sweden.
What does the study involve?
At the start of the study, participants have their skin autoflourescence measured using a special machine called an AGE reader This involves placing the forearm onto the machine which then shines light through the arm to measure the amount of light that is absorbed. The amount of AGE present in the skin can then be calculated. Participants then continue to receive dialysis using their usual glucose-containing dialysate for four weeks. Participants are then switched to a glucose-free dialysate. After the third and sixth dialysis session using the new dialysate (one and two weeks after the switch), the skin autoflourescence test is repeated.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involve with participating.
Where is the study run from?
Norrland University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2007 to May 2009
Who is funding the study?
1. Västerbotten Läns Landsting (Sweden)
2. Norrlands Kidney Patient Association (Sweden)
Who is the main contact?
Professor Bernd Stegmayr
bernd.stegmayr@umu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Bernd Stegmayr
ORCID ID
http://orcid.org/0000-0003-2694-7035
Contact details
Norrland University Hospital
Universitetssjukhuset
Umeå
90185
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Measuring skin- and plasmaautofluorescence in hemodialysis patients either with glucose free or glucose-containing dialysate
Acronym
Study hypothesis
The aim of this study is to investigate if the is a difference between the use of a dialysate not containing glucose compared with a glucose containing dialysate
Ethics approval
The Regional Ethical Review Board in Umeå. Dept. of Medical Research, 12/03/2008, ref: Dnr 08-023M
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Cardiovascular disease in hemodialysis patients
Intervention
Patients on chronic hemodialysis with glucose containing dialysis bath (contentration 5 mmol/L) continue their usual treatement for the initial four weeks of the study. Following this, the dialysis concentrate is switched to glucose free dialysate. The dialysis procedure does not differ by using a different dialysis concentrate.
At baseline and then one and two weeks after the dialysate switch (after the third and after the sixth dialysis treatment with glucose free dialysate), participants have their skin autofluorescence measured using anAGE Reader and their plasma autofluorescence measured uisng a Tecan Genios microplate reader.
Following the final measurement, the dialysate is changed back to the dialysate the participants were using prior to the study.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Skin autofluorescence is measured using the AGE Reader (DiagnOptics Technologies BV, Groningen, The Netherlands) at baseline, 1 and 2 weeks after dialysate is switched to glucose free dialysate.
Secondary outcome measures
Plasma autofluorescence is measured using a Tecan Genios microplate reader (Tecan Group Ltd., Männedorf, Switzerland) at baseline, 1 and 2 weeks after dialysate is switched to glucose free dialysate.
Overall trial start date
21/01/2007
Overall trial end date
11/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients (age > 18 years), no upper limit of age
2. Chronic dialysis treatment (patients with dialysis treatment more than three months)
3. All patients treated at the dialysis unit at Norrlands university hospital, Umeå, Sweden, who give informed consent and have no exclusion criterias
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Ongoing infection (elevated CRP)
2. Inability to understand information and give informed consent
3. Patients with diabetes mellitus prone to hypoglycemia
Recruitment start date
31/03/2009
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Norrland University Hospital
Universitetssjukhuset
Umeå
90185
Sweden
Funders
Funder type
Government
Funder name
Västerbotten Läns Landsting
Alternative name(s)
Västerbotten County Council
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Funder name
Norrlands Kidney Patient Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Bernd Stegmayr (bernd.stegmayr@umu.se) and Bernd Ramsauer (bernd.ramsauer@vgregion.se)
Intention to publish date
31/03/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28056864