Contact information
Type
Scientific
Primary contact
Dr Mike Sampson
ORCID ID
Contact details
Consultant Physician
Department of Diabetes and Endocrinology
Level 3
East Wing
Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 287094
mike.sampson@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547130898
Study information
Scientific title
Influence of hyperglycaemia on mononuclear cell DNA integrity and gene expression in relation to cardiovascular disease risk
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Not provided at time of registration
Overall trial start date
01/10/2003
Overall trial end date
01/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
30 patients with type 2 diabetes and 30 controls
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2003
Recruitment end date
01/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary