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

Sponsor

Keele University (Other)

Overall Status

Completed

CT.gov ID

NCT02042768

Collaborator

National Institute for Health Research, United Kingdom (Other), Baxter Healthcare Corporation (Industry), Kidney Cancer UK (Other)

1,451

Enrollment

Location

Actual Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism Disorders

Study Design

Study Type:

Observational

Actual Enrollment :

1451 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Mortality [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 Outcome Measures

Cardiovascular mortality [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