Can changes in dialysis treatment decrease substances which are related to ageing
| ISRCTN | ISRCTN13837553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13837553 |
| Secondary identifying numbers | 1 |
- Submission date
- 13/11/2016
- Registration date
- 16/11/2016
- Last edited
- 09/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Norrland University Hospital
Universitetssjukhuset
Umeå
90185
Sweden
 ORCID ID |
0000-0003-2694-7035 |
|---|
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Measuring skin- and plasmaautofluorescence in hemodialysis patients either with glucose free or glucose-containing dialysate |
| Study objectives | 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(s) | The Regional Ethical Review Board in Umeå. Dept. of Medical Research, 12/03/2008, ref: Dnr 08-023M |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 21/01/2007 |
| Completion date | 11/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key exclusion criteria | 1. Ongoing infection (elevated CRP) 2. Inability to understand information and give informed consent 3. Patients with diabetes mellitus prone to hypoglycemia |
| Date of first enrolment | 31/03/2009 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Umeå
90185
Sweden
Sponsor information
Hospital/treatment centre
Dept. of Nephrology
Dialysis unit
Universitetssjukhuset
Umeå
90185
Sweden
"ROR" |
https://ror.org/012k96e85 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Västerbotten County Council
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/01/2017 | Yes | No |
Editorial Notes
09/01/2017: Publication reference added.
