Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT02580266
Status:
WITHDRAWN
Last Update Posted:
2019-02-15
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, serum, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'funding withdrew', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular phenotype', 'timeFrame': '5 years', 'description': 'Cellular phenotype (gene and protein expression level)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney', 'Diabetes'], 'conditions': ['Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular complication of diabetes. New treatments are urgently needed for preventing or slowing down the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained from patients with diabetes and different degree of renal impairment.\n\nIn this project cells in culture will be treated with plasma or serum or urine; cells extracts or supernatant will be studied to screen for modulation (activation/inhibition) of different cellular pathways using gene array, metabolomic and/or proteomic. Once some cellular pathways have been identified specific analysis will be conducted on the biological material collected to confirm specific "cell signatures" that could represent potential target for treatment.', 'detailedDescription': 'The aim of the study is to investigate novel putative mechanisms involved in the pathophysiology of kidney disease in diabetic patients.\n\nThe investigators will make use of plasma, serum or urine obtained from patients with diabetes.\n\nCells in culture will be treated with plasma or serum or urine; cells extracts or supernatant will be studied to screen for modulation (activation/inhibition) of different cellular pathways using gene array, metabolomic and/or proteomic. Once some cellular pathways have been identified specific analysis will be conducted on the biological material collected to confirm specific "cell signatures" that could represent potential target for treatment.\n\nThe investigators will recruit patients with both type 1 and type 2 diabetes attending our outpatient diabetes clinic at Guys\' and St Thomas Hospital. The participant will be informed of the aim of the research and if agreeable in donating blood and urine sample; participants will be asked to sign a written informed consent explaining in simple word the aim of the research, the involvement they should have (blood sample and urine sample collection), the minimal risk to which they will be exposed (venopuncture).\n\nThe study will involve one or more blood collections from the arm, for up to 30 mls (6 tea spoons) per year (up to 10 yeas duration), to be collected on up to 2 occasions/ year (minimum time between two collections: 4 weeks), with up to 15ml (3 tea spoon) of blood maximum volume taken per occasion. Urine samples (any amount) might also be collected at any time. Blood and urine collections will take approximately 15 minutes.\n\nThis research is low risk. Samples will be stored within the Unit of Metabolic Medicine (Dr Gnudi), King\'s College London, United Kingdom, and its potential future use will be within the remit of the advancement of science and for the benefit of public domain within academic and/or commercial organisations (e.g. pharmaceutical industry) worldwide.\n\nAny information collected from participants during the course of the research will be kept strictly confidential. Any information leaving the hospital will have the name and address of patient removed so that it can not be recognised by third parties.\n\nThe results obtained from this research will likely to be published in a medical journal. The investigators will provide copy of any published results to anybody that may request for it. Participants will not be identified in any report/publication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 and type 2 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 and type 2 diabetes\n\nExclusion Criteria:\n\n* major acute cardio (myocardial infarct, stroke, ec) renal (acute renal failure) events, or severe debilitating disease (e.g. cancer) during the 6 months before the blood/urine collection.'}, 'identificationModule': {'nctId': 'NCT02580266', 'acronym': 'DDRD', 'briefTitle': 'Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes', 'orgStudyIdInfo': {'id': 'Version-2, 01 Sept 2015'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Unit for Metabolic Medicine, King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Luigi Gnudi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}