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

James Cook University Hospital
Clinical Trials Unit
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Email mary.bilous@stees.nhs.uk

Study information

Study designSingle-centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDiabetes UK Study
Study acronymDRN112 Nurse Led Multifactorial Intervention Study
Study objectivesChronic 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) studiedTopic: Diabetes Research Network; Subtopic: Type 2; Disease: Nephropathy, Cardiovascular disease, Hypertension, Dyslipidaemia, Diabetic Control, Multiple complications
Intervention1. 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 typeOther
Primary outcome measureCardiovascular mortality (obtained from tagging death certificates at OPCS)
Secondary outcome measuresMorbidity (based on patient questionnaire and interrogation of medical records)
Overall study start date03/12/2007
Completion date10/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 600; UK sample size: 600
Key inclusion criteria1. Type 2 diabetes
2. Estimated glomerular filtration rate (eGFR) 30 - 90 ml
3. Aged 18 - 76 years, either sex
Key exclusion criteria1. Type 1 diabetes
2. Pregnancy
Date of first enrolment03/12/2007
Date of final enrolment10/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

South Tees Hospitals NHS Foundation Trust (UK)
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 logo "ROR" https://ror.org/02js17r36

Funders

Funder type

Charity

Diabetes UK (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.