N/A
N=81
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02878317 ↗Enrolled (actual)
81
Serious AEs
—
Results posted
Dec 2024
Primary outcome: Primary: Skin Autofluorescence Levels at 6 Months — 3.7; 3.8 Arbitrary units
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nottingham
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Autofluorescence Levels at 6 Months |
3.7; 3.8 | — |
| SECONDARY Energy Intake at 6 Months. |
30.1; 18.9 | — |
| SECONDARY Nutritional Status at 6 Months |
5.0; 5.0 | — |
| SECONDARY Dietary Advanced Glycation End-products (AGE) Intake at 6 Months |
19074; 14697 | — |
| SECONDARY Protein Intake at 6 Months. |
1.1; 0.8 | — |
| SECONDARY Serum Albumin Levels at 6 Months |
31.5; 31.0 | — |
| SECONDARY Handgrip Strength at 6 Months |
16.7; 18.3 | — |
Summary
The purpose of the present study is to investigate the association between the accumulation of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as the impact of a dietetic intervention on AGE accumulation. AGE will be measured non-invasively in the skin using a technique called skin autofluorescence (SAF).
The present study will be conducted in two parts:
Study 1: this will be a prospective study where participants will be followed-up for up to five years. The research team will measure the accumulation of AGE in the skin using a quick (less than five minutes) and painless technique called SAF. This involves placing the forearm on a piece of equipment that shines a light on the skin and measures the amount of light that is reflected back. Participants will be asked to complete nutritional and quality of life questionnaires, measurements of weight, height, arm circumference and skinfold thickness (i.e. anthropometry), simple eyesight tests and blood tests.
Study 2: observational non-randomized proof of principle study where malnourished dialysis participants will receive a dietitian supervised intensive nutritional support. Participants will be followed-up for 2 years and will receive precise oral and written instructions on how to comply with the intervention. Blood and eyesight tests, SAF measurements, anthropometry and nutritional and quality of life assessments will be conducted.
In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE levels and do some additional blood tests to help us investigate the effects of AGEs on the body. If the participants agree, the investigators will also store some of the blood for future research.
Eligibility Criteria
Inclusion Criteria
Haemodialysis cohort:
- Three dialysis sessions per week for 4 hours.
- Dialysis with biocompatible membranes.
- Able to give informed consent.
Peritoneal Dialysis cohort:
- Dialysis with lactate/bicarbonate-buffered solutions with different glucose concentrations as prescribed for routine clinical care.
- Able to give informed consent.
Exclusion Criteria
- Does not wish to participate.
- Renal transplant.
- Pregnancy or breast feeding or intending pregnancy.
- Expected survival less than one year.
Data sourced from ClinicalTrials.gov (NCT02878317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.