Contact information
Type
Scientific
Primary contact
Ms Mary Bilous
ORCID ID
Contact details
James Cook University Hospital
Clinical Trials Unit
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
-
mary.bilous@stees.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4136
Study information
Scientific title
Diabetes UK Study
Acronym
DRN112 Nurse Led Multifactorial Intervention Study
Study hypothesis
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
MREC, 14/05/2007, ref: 07/Q1001/32
Study design
Single-centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Cardiovascular mortality (obtained from tagging death certificates at OPCS)
Secondary outcome measures
Morbidity (based on patient questionnaire and interrogation of medical records)
Overall trial start date
03/12/2007
Overall trial end date
10/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes
2. Estimated glomerular filtration rate (eGFR) 30 - 90 ml
3. Aged 18 - 76 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 600; UK sample size: 600
Participant exclusion criteria
1. Type 1 diabetes
2. Pregnancy
Recruitment start date
03/12/2007
Recruitment end date
10/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
South Tees Hospitals NHS Foundation Trust (UK)
Sponsor details
James Cook University Hospital
Clinical Trials Unit
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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