Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042768

Acronym

PD-CRAFT

Enrollment

1451

Registered

2014-01-23

Start date

2013-03-31

Completion date

2020-12-31

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

Keywords

Glucose, Dialysate, Peritoneal Dialysis, patients, non-diabetic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* On peritoneal dialysis

Exclusion criteria

* Not providing informed consent. * Diabetes.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results