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United Kingdom Asian Diabetes Study
ISRCTN ISRCTN38297969
DOI 10.1186/ISRCTN38297969
ClinicalTrials.gov identifier
EudraCT number
Public title United Kingdom Asian Diabetes Study
Scientific title
Acronym UKADS
Serial number at source 2
Study hypothesis Structured 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Type 2 diabetes
Participants - inclusion criteria Patients of South Asian ethnic background with type 2 diabetes.
Participants - exclusion criteria 1. Patients not of South Asian ethnic background
2. Diabetes other than type 2 diabetes
Anticipated start date 01/03/2004
Anticipated end date 01/03/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1800
Interventions A 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
Primary outcome measure(s) Acheivement 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 measure(s) 1. Development and progression of microalbuminuria and proteinuria
2. Mortality from any cause
3. Micro- and macro-vascular complications
Sources of funding 1. Pfizer Ltd (UK)
2. Sanofi-Aventis (UK)
3. Servier Laboratories Ltd (UK)
4. Merck, Sharp and Dohme - Schering Plough Limited (UK)
5. Takeda Ltd (UK)
6. Merck Pharmaceuticals (UK)
7. Eli Lilly and Company Limited (UK)
8. Novo Nordisk Ltd (UK)
9. Boehringer Ingelheim GmbH (Germany)
10. British Heart Foundation (UK)
Trial website
Publications 1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15569141
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18502301
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19725958
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20528107
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22106977
Contact name Prof  Anthony  Barnett
  Address Undergraduate Centre
Birmingham Heartlands Hospital
Bordesley Green East
  City/town Birmingham
  Zip/Postcode B9 5SS
  Country United Kingdom
  Tel +44 (0)121 424 3587
  Fax +44 (0)121 424 0593
  Email anthony.barnett@heartofengland.nhs.uk
Sponsor Heart of England NHS Foundation Trust (UK)
  Address Birmingham Heartlands Hospital
Bordesley Green East
  City/town Birmingham
  Zip/Postcode B9 5SS
  Country United Kingdom
  Tel +44 (0)121 424 3632
  Email elizabeth.adey@heartofengland.nhs.uk
Date applied 23/08/2005
Last edited 14/11/2013
Date ISRCTN assigned 14/09/2005
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