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

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ClinicalTrials.gov Identifier: NCT02042768
Recruitment Status : Recruiting
First Posted : January 23, 2014
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Baxter Healthcare Corporation
Kidney Cancer UK
Information provided by (Responsible Party):
Keele University

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
Glucose Metabolism Disorders

Study Type : Observational
Estimated Enrollment : 1600 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
Study Start Date : March 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019



Primary Outcome Measures :
  1. Mortality [ Time Frame: 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 :
  1. Cardiovascular mortality [ Time Frame: 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


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • On peritoneal dialysis

Exclusion Criteria:

  • Not providing informed consent.
  • Diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042768


Contacts
Contact: Louise Phillips-Darby, PhD l.phillips-darby@keele.ac.uk
Contact: Mark Lambie, MD m.lambie@keele.ac.uk

Locations
United Kingdom
University Hospital of North Staffordshire Recruiting
Stoke-on-Trent, North Staffordshire, United Kingdom, ST4 6QG
Contact: Hayley King       hayley.king@uhns.nhs.uk   
Principal Investigator: Simon Davies, MD         
Sponsors and Collaborators
Keele University
National Institute for Health Research, United Kingdom
Baxter Healthcare Corporation
Kidney Cancer UK
Investigators
Principal Investigator: Mark Lambie, MD Keele University

Additional Information:
Responsible Party: Keele University
ClinicalTrials.gov Identifier: NCT02042768     History of Changes
Other Study ID Numbers: 010/12
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Keele University:
Glucose
Dialysate
Peritoneal Dialysis
patients
non-diabetic

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders
Dialysis Solutions
Pharmaceutical Solutions