Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-25 @ 8:30 AM
Study NCT ID:
NCT02042768
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2014-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.\n\n30mls of spent dialysate stored in both filtered and unfiltered aliquots on all patients on PD for more than 3 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Patients will be followed up for the duration of the study period, an expected average of 24 months', 'description': 'From study entry to date of death from any cause, assessed up to June 2015'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': 'Patients will be followed up for the duration of the study period, an expected average of 24 months', 'description': 'From study entry up to date of death from cardiovascular cause, assessed up to June 2015'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose', 'Dialysate', 'Peritoneal Dialysis', 'patients', 'non-diabetic'], 'conditions': ['Glucose Metabolism Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.keele.ac.uk/pd-craft/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPD-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).\n\nMultivariate 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On peritoneal dialysis\n\nExclusion Criteria:\n\n* Not providing informed consent.\n* Diabetes.'}, 'identificationModule': {'nctId': 'NCT02042768', 'acronym': 'PD-CRAFT', 'briefTitle': 'Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This', 'organization': {'class': 'OTHER', 'fullName': 'Keele University'}, 'officialTitle': 'An Investigation of the Effects of Different Dialysis Prescriptions on Systemic Glucose Metabolism and Mortality in Non-diabetic Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'RG-0077-16, 010/12'}}, 'contactsLocationsModule': {'locations': [{'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'state': 'North Staffordshire', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Mark Lambie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keele University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keele University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, {'name': 'Kidney Cancer UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}