Influence of hyperglycaemia on mononuclear cell DNA integrity and gene expression in relation to cardiovascular disease risk

ISRCTN	ISRCTN20662850
DOI	https://doi.org/10.1186/ISRCTN20662850
Secondary identifying numbers	N0547130898

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 26/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Sampson
Scientific

Consultant Physician
Department of Diabetes and Endocrinology
Level 3, East Wing
Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom

Phone	+44 (0)1603 287094
Email	mike.sampson@nnuh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Influence of hyperglycaemia on mononuclear cell DNA integrity and gene expression in relation to cardiovascular disease risk
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Diabetes
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	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 study start date	01/10/2003
Completion date	01/10/2005

Eligibility

Participant type(s)	Mixed
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	30 patients with type 2 diabetes and 30 controls
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2003
Date of final enrolment	01/10/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Norfolk and Norwich University Hospital NHS Trust

Norwich
NR4 7UY
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

26/04/2018: No publications found, verifying study status with principal investigator.
22/03/2016: No publications found, verifying study status with principal investigator