Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This (PD-CRAFT)

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders

• Study Type: Observational
• Enrollment (Actual): 1451

Contacts and Locations

Study Locations

• United Kingdom
  • North Staffordshire
    • Stoke-on-Trent, North Staffordshire, United Kingdom, ST4 6QG
      • University Hospital of North Staffordshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All incident and prevalent non-diabetic peritoneal dialysis patients at centres participating in PD-CRAFT in the UK. PD-CRAFT is designed to oversample patients on PD for longer periods of time.

Description

Inclusion Criteria:

• On peritoneal dialysis

Exclusion Criteria:

• Not providing informed consent.
• Diabetes.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	From study entry to date of death from any cause, assessed up to June 2015	Patients will be followed up for the duration of the study period, an expected average of 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	From study entry up to date of death from cardiovascular cause, assessed up to June 2015	Patients will be followed up for the duration of the study period, an expected average of 24 months

Collaborators and Investigators

• Sponsor: Keele University
• Collaborators: Baxter Healthcare Corporation; National Institute for Health Research, United Kingdom; Kidney Cancer UK
• Investigators: Principal Investigator: Mark Lambie, MD, Keele University

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: patients; Glucose; Peritoneal Dialysis; non-diabetic; Dialysate
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: RG-0077-16, 010/12