Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This

Glucose Metabolism Disorders Clinical Trial

— PD-CRAFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042768
• Other study ID #: RG-0077-16, 010/12
• Status: Completed
• Start date: March 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: Keele University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1451
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• On peritoneal dialysis

Exclusion Criteria:

• Not providing informed consent.

• Diabetes.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
United Kingdom	University Hospital of North Staffordshire	Stoke-on-Trent	North Staffordshire

Sponsors (4)

Lead Sponsor	Collaborator
Keele University	Baxter Healthcare Corporation, Kidney Cancer UK, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Study website