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
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|
|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|
- 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
- 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.
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
|Contact: Louise Phillips-Darby, PhDfirstname.lastname@example.org|
|Contact: Mark Lambie, MDemail@example.com|
|University Hospital of North Staffordshire||Recruiting|
|Stoke-on-Trent, North Staffordshire, United Kingdom, ST4 6QG|
|Contact: Hayley King firstname.lastname@example.org|
|Principal Investigator: Simon Davies, MD|
|Principal Investigator:||Mark Lambie, MD||Keele University|