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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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DRN 660 (Paraoxonase and HDL qualities in glycaemia and inflammation)
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Changes in paraoxonase activity, HDL properties, inflammatory markers and corneal innervation in post-bariatric surgery patients, type 1 diabetics with and without nephropathy, type 2 diabetics, and during an oral glucose tolerance test.
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Topic
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Diabetes (co-adopted by Cardiovascular, Generic Relevance & Cross Cutting Themes)
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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EudraCT
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MREC N°
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UKCRN ID
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11607
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WHO ID
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Study Type
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Both
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Design Type
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Treatment, Cohort study
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Disease(s)
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Retinopathy
Neuropathy
Cardiovascular disease
Dyslipidaemia
Metabolic
Obesity
Surgery
Cardiovascular Prevention
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Phase
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Experimental Medicine
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Current Status
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Open
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Closure Date
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12/31/2018
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Global Sample Size
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720
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Global Recruitment to Date
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 3% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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No
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Main Inclusion Criteria
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Patients with Type 1 diabetes who are not receiving lipidlowering
drugs, omega fatty acid supplements or thiazolidinediones and without clinical and/or ECG evidence of CHD.
Type 2 diabetic patients who are not receiving omega fatty acid supplements or thiazolidinediones and without clinical and/or ECG evidence of CHD.
Patients with impaired fasting glucose undergoing oral glucose tolerance test.
Patients scheduled for bariatric surgery.
Healthy controls who have no major acute or chronic illness, are not receiving regular medication and not taking omega fatty acid supplements, do not have clinically overt ischaemic heart disease.
Subjects (male and female) aged between 20 and 75.
Subjects who have capacity and understanding for informed consent process.
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Main Exclusion Criteria
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Type 1 diabetics using lipid lowering therapy, thiazolidinediones, omega fatty acid supplements. History and/or ECG
evidence of ST segment changes indicative of CHD.
Type 2 diabetics receiving thiazolidinediones, omega fatty acid supplements. History and/or ECG evidence of ST segment changes indicative of CHD.
Healthy controls who have any history of CHD, vascular insufficiency, or diabetes. Use of any lipid-lowering drug or omega fatty acid supplements.
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Chief Investigator(s)
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| Prof Handrean Soran |
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Further details, please contact
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Dr See Kwok
Manchester Royal Infirmary
Manchester Royal Infirmary
Oxford Road
Manchester
Greater Manchester
M13 9WL
UNITED KINGDOM
Tel: 1612764682
sk7@doctors.org.uk
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| Funder(s) |
British Heart Foundation (BHF)
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| Sponsor(s) |
Central Manchester & Manchester Childrens University Hospital
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