Diabetes UK Study
| ISRCTN | ISRCTN85900874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85900874 |
| Protocol serial number | 4136 |
| Sponsor | South Tees Hospitals NHS Foundation Trust (UK) |
| Funder | Diabetes UK (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Cardiovascular mortality (obtained from tagging death certificates at OPCS) |
| Key secondary outcome measure(s) |
Morbidity (based on patient questionnaire and interrogation of medical records) |
| Completion date | 10/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
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 |
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.
