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 |
| Protocol serial number | N0547130898 |
| Sponsor | Department of Health |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK) |
- 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
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 |
|---|---|
| mike.sampson@nnuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
