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Register:	ISRCTN
Last refreshed on:	6 February 2017
Main ID:	ISRCTN13837553
Date of registration:	16/11/2016
Prospective Registration:	No
Primary sponsor:	Norrlands University Hospital
Public title:	Can changes in dialysis treatment decrease substances which are related to ageing
Scientific title:	Measuring skin- and plasmaautofluorescence in hemodialysis patients either with glucose free or glucose-containing dialysate
Date of first enrolment:	31/03/2009
Target sample size:	24
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN13837553
Study type:	Interventional
Study design:	Non-randomised study (Other)
Phase:

Countries of recruitment
Sweden

Contacts

Name:	Bernd Stegmayr
Address:	Norrland University Hospital Universitetssjukhuset 90185 Umeå Sweden
Telephone:
Email:
Affiliation:

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Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Ongoing infection (elevated CRP)
2. Inability to understand information and give informed consent
3. Patients with diabetes mellitus prone to hypoglycemia

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular disease in hemodialysis patients
Circulatory System
Cardiovascular disease in hemodialysis patients

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

Source(s) of Monetary Support

Västerbotten Läns Landsting, Norrlands Kidney Patient Association

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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