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Completed

NCT Number: NCT02042768

Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This

Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the most commonly used dialysate contains unphysiological amounts of glucose, a high proportion of which is absorbed. Recent analysis of the Global Fluid Study, has established that in non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate glucose load and is a predictor of death. By utilising clinical data and additional biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm this finding, define the relationship between dialysate glucose exposure according to prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia , and establish the role that impaired insulin sensitivity plays in blood glucose levels. Furthermore the investigators will explore the hypothesis that insulin resistance is associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit from intra-peritoneal carnitine supplementation.

PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed clinical data, including glucose exposure and samples of dialysate. and blood which will be stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique failure).

Multivariate regression will be used to establish determinants of the non-fasting blood glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g. modality, dwell lengths, fill volumes, and dialysate type and concentration specifically seeking to identify prescriptions that minimise the systemic effects) combined with measures of insulin resistance. The investigators will establish whether blood glucose predicts survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore the relationship of other biomarkers to survival.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Staffordshire

Stoke-on-Trent, North Staffordshire, ST4 6QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On peritoneal dialysis

Exclusion criteria

  • Not providing informed consent.
  • Diabetes.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Patients will be followed up for the duration of the study period, an expected average of 24 months

    From study entry to date of death from any cause, assessed up to June 2015

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: Patients will be followed up for the duration of the study period, an expected average of 24 months

    From study entry up to date of death from cardiovascular cause, assessed up to June 2015

Sponsors and collaborators

Lead sponsor

Keele University

Other

Collaborators

  • Baxter Healthcare Corporation
  • Kidney Cancer UK
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

An Investigation of the Effects of Different Dialysis Prescriptions on Systemic Glucose Metabolism and Mortality in Non-diabetic Peritoneal Dialysis Patients

Acronym: PD-CRAFT

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Jan 23, 2014
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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