Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.southtees.nhs.uk/live

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

Publication citations

Additional files

Editorial Notes