United Kingdom Asian Diabetes Study

ISRCTN	ISRCTN38297969
DOI	https://doi.org/10.1186/ISRCTN38297969
Protocol serial number	2
Sponsor	Heart of England NHS Foundation Trust (UK)
Funders	Pfizer Ltd (UK), Sanofi-Aventis (UK), Servier Laboratories Ltd (UK), Merck, Sharp and Dohme - Schering Plough Limited (UK), Takeda Ltd (UK), Merck Pharmaceuticals (UK), Eli Lilly and Company Limited (UK), Novo Nordisk Ltd (UK), Boehringer Ingelheim GmbH (Germany), British Heart Foundation (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	UKADS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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%)
Key secondary outcome measure(s)	1. Development and progression of microalbuminuria and proteinuria 2. Mortality from any cause 3. Micro- and macro-vascular complications
Completion date	01/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1800
Key inclusion criteria	Patients of South Asian ethnic background with type 2 diabetes.
Key exclusion criteria	1. Patients not of South Asian ethnic background 2. Diabetes other than type 2 diabetes
Date of first enrolment	01/03/2004
Date of final enrolment	01/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Undergraduate Centre

Birmingham
B9 5SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes