Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes
NCT ID: NCT02580266
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-09-30
2025-09-30
Brief Summary
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In 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.
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Detailed Description
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The investigators will make use of plasma, serum or urine obtained from patients with diabetes.
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.
The 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).
The 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.
This 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.
Any 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.
The 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Luigi Gnudi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Unit for Metabolic Medicine, King's College London
London, , United Kingdom
Countries
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Other Identifiers
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Version-2, 01 Sept 2015
Identifier Type: -
Identifier Source: org_study_id
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