- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02042768
Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This (PD-CRAFT)
An Investigation of the Effects of Different Dialysis Prescriptions on Systemic Glucose Metabolism and Mortality in Non-diabetic Peritoneal Dialysis Patients
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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North Staffordshire
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Stoke-on-Trent, North Staffordshire, Det Forenede Kongerige, ST4 6QG
- University Hospital of North Staffordshire
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- On peritoneal dialysis
Exclusion Criteria:
- Not providing informed consent.
- Diabetes.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: 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
|
Patients will be followed up for the duration of the study period, an expected average of 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiovascular mortality
Tidsramme: 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
|
Patients will be followed up for the duration of the study period, an expected average of 24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Lambie, MD, Keele University
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RG-0077-16, 010/12
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