United Kingdom Asian Diabetes Study
| ISRCTN | ISRCTN38297969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38297969 |
| Secondary identifying numbers | 2 |
- 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
Scientific
Undergraduate Centre
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
| Phone | +44 (0)121 424 3587 |
|---|---|
| anthony.barnett@heartofengland.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2004 |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Undergraduate Centre
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom
| Phone | +44 (0)121 424 3632 |
|---|---|
| elizabeth.adey@heartofengland.nhs.uk |
Funders
Funder type
Industry
Pfizer Ltd (UK)
No information available
Sanofi-Aventis (UK)
No information available
Servier Laboratories Ltd (UK)
No information available
Merck, Sharp and Dohme - Schering Plough Limited (UK)
No information available
Takeda Ltd (UK)
No information available
Merck Pharmaceuticals (UK)
No information available
Eli Lilly and Company Limited (UK)
No information available
Novo Nordisk Ltd (UK)
No information available
Boehringer Ingelheim GmbH (Germany)
No information available
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
