ISRCTN ISRCTN38297969
DOI https://doi.org/10.1186/ISRCTN38297969
Secondary identifying numbers 2
Submission date
23/08/2005
Registration date
14/09/2005
Last edited
14/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anthony Barnett
Scientific

Undergraduate Centre
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Phone +44 (0)121 424 3587
Email anthony.barnett@heartofengland.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymUKADS
Study objectivesStructured care for diabetes, tailored to the needs of the Asian community, will improve surrogate endpoints for diabetic complications (and by extrapolation morbidity and mortality) in South Asian patients with type 2 diabetes. This will require the extra resources of Asian link workers, additional practice nurse time and community Diabetes Specialist Nurse input, working to protocols with clearly defined targets.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionA complex intervention package comprising specialist diabetes nurse co-ordinators working with practice nurses to implement protocols for the treatment of blood pressure, blood lipid and blood glucose levels. The protocols use simple treatment algorithms and have strict targets. Practice nurse time and training are protected and enhanced, and practice nurses work with Asian link workers to facilitate cultural acceptability of treatment and compliance. DNA samples will be prepared in order to investigate the genetic determinants of high density lipoprotein (HDL) cholesterol levels and latent autoimmune diabetes of adults (LADA), the genetic susceptibility to microalbuminuria and candidate susceptibility genes for type 2 diabetes and components of the metabolic syndrome.
Control: usual care
Intervention typeOther
Primary outcome measureAcheivement of targets as set out in treatment algorithms:
1. Blood pressure (130/80 mmHg)
2. Lipid profile (total cholesterol less than 4.0 mmol/l, low density lioprotein [LDL] cholesterol less than 2.5 mmol/l, triglycerides less than 2.0 mmol/l)
3. Glycaemic control (HbA1c less than 7.0%)
Secondary outcome measures1. Development and progression of microalbuminuria and proteinuria
2. Mortality from any cause
3. Micro- and macro-vascular complications
Overall study start date01/03/2004
Completion date01/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1800
Key inclusion criteriaPatients of South Asian ethnic background with type 2 diabetes.
Key exclusion criteria1. Patients not of South Asian ethnic background
2. Diabetes other than type 2 diabetes
Date of first enrolment01/03/2004
Date of final enrolment01/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Undergraduate Centre
Birmingham
B9 5SS
United Kingdom

Sponsor information

Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom

Phone +44 (0)121 424 3632
Email elizabeth.adey@heartofengland.nhs.uk

Funders

Funder type

Industry

Pfizer Ltd (UK)

No information available

Sanofi-Aventis (UK)

No information available

Servier Laboratories Ltd (UK)

No information available

Merck, Sharp and Dohme - Schering Plough Limited (UK)

No information available

Takeda Ltd (UK)

No information available

Merck Pharmaceuticals (UK)

No information available

Eli Lilly and Company Limited (UK)

No information available

Novo Nordisk Ltd (UK)

No information available

Boehringer Ingelheim GmbH (Germany)

No information available

British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2004 Yes No
Results article results 24/05/2008 Yes No
Results article results 02/09/2009 Yes No
Results article results 01/08/2010 Yes No
Results article results 01/11/2011 Yes No