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ISRCTN
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ISRCTN38297969
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ClinicalTrials.gov identifier
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Public title
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United Kingdom Asian Diabetes Study
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Scientific title
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Acronym
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UKADS
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Serial number at source
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2
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Type 2 diabetes
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Participants - inclusion criteria
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Patients of South Asian ethnic background with type 2 diabetes.
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Participants - exclusion criteria
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1. Patients not of South Asian ethnic background
2. Diabetes other than type 2 diabetes
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Anticipated start date
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01/03/2004
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Anticipated end date
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01/03/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1800
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Interventions
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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
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Primary outcome measure(s)
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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%)
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Secondary outcome measure(s)
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1. Development and progression of microalbuminuria and proteinuria
2. Mortality from any cause
3. Micro- and macro-vascular complications
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Sources of funding
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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)
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Trial website
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Publications
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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
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Contact name
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Prof
Anthony
Barnett
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Address
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Undergraduate Centre
Birmingham Heartlands Hospital
Bordesley Green East
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Tel
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+44 (0)121 424 3587
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Fax
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+44 (0)121 424 0593
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Email
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anthony.barnett@heartofengland.nhs.uk
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Sponsor
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Heart of England NHS Foundation Trust (UK)
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Address
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Birmingham Heartlands Hospital
Bordesley Green East
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Tel
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+44 (0)121 424 3632
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Email
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elizabeth.adey@heartofengland.nhs.uk
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Date applied
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23/08/2005
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Last edited
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11/06/2010
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Date ISRCTN assigned
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14/09/2005
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