Contact information
Type
Scientific
Primary contact
Prof Anthony Barnett
ORCID ID
Contact details
Undergraduate Centre
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 3587
anthony.barnett@heartofengland.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2
Study information
Scientific title
Acronym
UKADS
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
1. Development and progression of microalbuminuria and proteinuria
2. Mortality from any cause
3. Micro- and macro-vascular complications
Overall trial start date
01/03/2004
Overall trial end date
01/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients of South Asian ethnic background with type 2 diabetes.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1800
Participant exclusion criteria
1. Patients not of South Asian ethnic background
2. Diabetes other than type 2 diabetes
Recruitment start date
01/03/2004
Recruitment end date
01/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Undergraduate Centre
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust (UK)
Sponsor details
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 3632
elizabeth.adey@heartofengland.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Pfizer Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi-Aventis (UK)
Alternative name(s)
Funding Body Type
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Location
Funder name
Servier Laboratories Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Merck, Sharp and Dohme - Schering Plough Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Takeda Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Merck Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Eli Lilly and Company Limited (UK)
Alternative name(s)
Funding Body Type
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Location
Funder name
Novo Nordisk Ltd (UK)
Alternative name(s)
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Location
Funder name
Boehringer Ingelheim GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
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
Publication citations
-
Results
O'Hare JP, Raymond NT, Mughal S, Dodd L, Hanif W, Ahmad Y, Mishra K, Jones A, Kumar S, Szczepura A, Hillhouse EW, Barnett AH, , Evaluation of delivery of enhanced diabetes care to patients of South Asian ethnicity: the United Kingdom Asian Diabetes Study (UKADS)., Diabet. Med., 2004, 21, 12, 1357-1365, doi: 10.1111/j.1464-5491.2004.01373.x.
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Results
Bellary S, O'Hare JP, Raymond NT, Gumber A, Mughal S, Szczepura A, Kumar S, Barnett AH, , Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial., Lancet, 2008, 371, 9626, 1769-1776, doi: 10.1016/S0140-6736(08)60764-3.
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Results
Rees SD, Britten AC, Bellary S, O'Hare JP, Kumar S, Barnett AH, Kelly MA, The promoter polymorphism -232C/G of the PCK1 gene is associated with type 2 diabetes in a UK-resident South Asian population., BMC Med. Genet., 2009, 10, 83, doi: 10.1186/1471-2350-10-83.
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Results
Bellary S, O'Hare JP, Raymond NT, Mughal S, Hanif WM, Jones A, Kumar S, Barnett AH, Premature cardiovascular events and mortality in south Asians with type 2 diabetes in the United Kingdom Asian Diabetes Study - effect of ethnicity on risk., Curr Med Res Opin, 2010, 26, 8, 1873-1879, doi: 10.1185/03007995.2010.490468.
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Results
Raymond NT, Paul O'Hare J, Bellary S, Kumar S, Jones A, Barnett AH, , Comparative risk of microalbuminuria and proteinuria in UK residents of south Asian and white European ethnic background with type 2 diabetes: a report from UKADS., Curr Med Res Opin, 2011, 27 Suppl 3, 47-55, doi: 10.1185/03007995.2011.614937.