Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/08/2005
Date assigned
14/09/2005
Last edited
14/11/2013
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

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 measures

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

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

Funding Body Subtype

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

Funding Body Subtype

Location

Funder name

Novo Nordisk Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

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

private sector organisation

Funding Body Subtype

foundation

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

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes