Diabetes Complications Clinical Trial
Official title:
Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes
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.
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.
The aim of the study is to investigate novel putative mechanisms involved in the
pathophysiology of kidney disease in diabetic patients.
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.
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