Diabetes UK Study
| ISRCTN | ISRCTN85900874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85900874 |
| Secondary identifying numbers | 4136 |
- Submission date
- 21/10/2010
- Registration date
- 21/10/2010
- Last edited
- 06/09/2019
- 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
Ms Mary Bilous
Scientific
Scientific
James Cook University Hospital
Clinical Trials Unit
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| mary.bilous@stees.nhs.uk |
Study information
| Study design | Single-centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Diabetes UK Study |
| Study acronym | DRN112 Nurse Led Multifactorial Intervention Study |
| Study objectives | Chronic kidney disease is an independent risk factor for cardiovascular morbidity and mortality. We have previously shown that mortality rates increase exponentially as eGFR declines. This study set out to see whether a multi-factorial cardiovascular risk factor intervention performed by specialist nurses conferred benefit in terms of cardiovascular morbidity and mortality in patients with type 2 diabetes and an estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 m2. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4136 |
| Ethics approval(s) | MREC, 14/05/2007, ref: 07/Q1001/32 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Nephropathy, Cardiovascular disease, Hypertension, Dyslipidaemia, Diabetic Control, Multiple complications |
| Intervention | 1. Achieve blood pressure target less than 130/85 mmHg 2. Achieve HbA1c less than 7% 3. Achieve low density lipoprotein (LDL) cholesterol less than 2 mmol 4. Achieve weight loss of greater than 10% or ideal body weight 5. Detect and correct anaemia to 11 g/dl 6. Correct secondary hyperparathyroidism where detected 7. Increase activity/exercise 8. Stop smoking Follow up length: 60 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | Cardiovascular mortality (obtained from tagging death certificates at OPCS) |
| Secondary outcome measures | Morbidity (based on patient questionnaire and interrogation of medical records) |
| Overall study start date | 03/12/2007 |
| Completion date | 10/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 600; UK sample size: 600 |
| Key inclusion criteria | 1. Type 2 diabetes 2. Estimated glomerular filtration rate (eGFR) 30 - 90 ml 3. Aged 18 - 76 years, either sex |
| Key exclusion criteria | 1. Type 1 diabetes 2. Pregnancy |
| Date of first enrolment | 03/12/2007 |
| Date of final enrolment | 10/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
South Tees Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
James Cook University Hospital
Clinical Trials Unit
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Website | http://www.southtees.nhs.uk/live |
|---|---|
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
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
06/09/2019: No publications found, verifying study status with principal investigator.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
