Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

22/03/2016: No publications found, verifying study status with principal investigator