Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This

NCT02042768 | Completed

• 1 other identifier: RG-0077-16, 010/12
• Study Type: observational
• Target: 1,451
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cardiovascular mortality

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• On peritoneal dialysis

You may not qualify if:

• Not providing informed consent.
• Diabetes.

Sponsors & Collaborators

• Keele University: lead
• National Institute for Health Research, United Kingdom: collaborator
• Baxter Healthcare Corporation: collaborator
• Kidney Cancer UK: collaborator

Study Sites (1)

University Hospital of North Staffordshire

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

Location

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITH DNA

Blood stored in EDTA for assays including DNA on all PD-CRAFT patients. 10mls blood in EDTA taken during PET on all patients eligible for glucose study. 30mls of spent dialysate stored in both filtered and unfiltered aliquots on all patients on PD for more than 3 years.

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark Lambie, MD

  Keele University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 23, 2014
• Study Start: March 1, 2013
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

GB (1)