CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 4
  • Hemodialysis patients receiving three sessions per week for 4 hours each
  • Hemodialysis with biocompatible membranes
  • Peritoneal dialysis with lactate/bicarbonate-buffered solutions
  • Able to provide informed consent
Key exclusion· 3
  • Renal transplant recipients
  • Pregnant, breastfeeding, or planning pregnancy
  • Expected survival less than one year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02878317
NCT02878317N/ACompleted

Association of Advanced Glycation End-product Accumulation and Adverse Outcomes in Peritoneal Dialysis and Haemodialysis Patients and the Impact of a Dietetic Intervention on Skin Autofluorescence

University of Nottingham·observational·Posted Aug 25, 2016·Updated Dec 10, 2024

In Brief

An observational study for Chronic Kidney Disease. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartSep 21, 2016
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.9 years ago