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11 February 2012 
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Influence of Hyperglycaemia on Mononuclear Cell DNA Integrity and Gene Expression in Relation to Cardiovascular Disease Risk
ISRCTN ISRCTN20662850
ClinicalTrials.gov identifier
Public title Influence of Hyperglycaemia on Mononuclear Cell DNA Integrity and Gene Expression in Relation to Cardiovascular Disease Risk
Scientific title
Acronym N/A
Serial number at source N0547130898
Study hypothesis The expression of cardiovascular disease (CVD)-risk-associated genes will be increased at baseline in patients with Type 2 diabetes compared with non-diabetic individuals, and the expression of these genes will be up-regulated following an acute glucose load, and will be repressed following antioxidant supplementation in patients with Type 2 diabetes.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Nutritional, Metabolic, Endocrine: Diabetes
Participants - inclusion criteria 30 patients with type 2 diabetes and 30 controls
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/10/2003
Anticipated end date 01/10/2005
Status of trial Completed
Patient information material
Target number of participants 60
Interventions Not provided at time of registration
Primary outcome measure(s) Controls will be recruited from the Institute of Food Research's (IFR's) Human Nutrition Unit volunteer database, the Diabetes Centre database and by media reporting (local newspaper feature).
Secondary outcome measure(s) Not provided at time of registration
Sources of funding East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK)
Trial website
Publications
Contact name Dr  Mike  Sampson
  Address Consultant Physician
Department of Diabetes and Endocrinology
Level 3, East Wing
Norfolk and Norwich University Hospital NHS Trust
  City/town Norwich
  Zip/Postcode NR4 7UY
  Country United Kingdom
  Tel +44 (0)1603 287094
  Fax +44 (0)1603 287320
  Email mike.sampson@nnuh.nhs.uk
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 15/02/2010
Date ISRCTN assigned 30/09/2004
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