Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes (UNITED)
Recruitment status was Recruiting
Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with monogenic diabetes can often be treated with tablets rather than insulin injections, leading to better control of their diabetes, and fewer side-effects and complications. Less than 5% of people with monogenic diabetes in the UK have been identified, meaning up to 20,000 patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the necessary tests to ensure they have the correct treatment for their particular type of diabetes. A small number of people may, as part of this study, be found to have a specific genetic cause of their diabetes and in these cases we will measure the success and benefits of changing their treatment, usually from insulin injections to sulphonylurea tablets.
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes|
- Identification of patients with monogenic diabetes [ Time Frame: Within 4 years from start of project ] [ Designated as safety issue: No ]The aim of this project is to identify the prevalence of patients with monogenic diabetes resulting from mutations in the HNF1A/HNF4A/GCK genes, amongst patients with early-onset diabetes, diagnosed less than 30 years.
- To examine the impact of making a diagnosis of monogenic diabetes on patients' treatment, glucose control and quality of life. [ Time Frame: Within 4 years of the project start date. ] [ Designated as safety issue: No ]
To measure the impact of making a molecular genetic diagnosis of monogenic diabetes by examining at baseline, 1 month, 6 months and 12 months the following parameters:
i) treatment - both type and dose; ii) glucose control - measured by HbA1c at 3, 6 and 12 months post-treatment change; iii) quality of life - by appropriate protocols.
- To develop a health economic model of the care pathway leading to testing of monogenic diabetes. [ Time Frame: Within 4 years of the project start date. ] [ Designated as safety issue: No ]To develop a health economic model that can measure the success, cost and potential economic benefit of using the care pathway to identify patients with monogenic diabetes and potentially change their treatment. This will allow assessment of when testing is appropriate on health economic grounds.
Biospecimen Retention: Samples With DNA
Samples with DNA and plasma samples.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Diabetes diagnosed under 30 years
Patients currently under 50 years of age diagnosed with diabetes under 30 years.
Other: patient care pathway
Stage 1: Urinary c-peptide creatinine ratio (UCPCR); if positive progress to Stage 2.
Stage 2: Pancreatic auto-antibodies measurement (GAD65 & IA2); if negative progress to genetic testing.
Genetic testing for HNF1A, HNF4A, GCK. If positive, progress to Stage 3.
Stage 3: review and potential change of diabetes treatment. Monitor success via use of three standardised health and quality of life questionnaires and Hba1c pre-treatment change and at 1, 3, 6 and 12 months post-treatment change.
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|Contact: Andrew T Hattersley, DM Oxford||+44 (0)1392 email@example.com|
|Contact: Maggie H Shepherd, PhD Exeter||+44 (0)1392 firstname.lastname@example.org|
|Peninsula NIHR Clinical Research Facility, Peninsula Medical School, Barrack Rd,||Recruiting|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Contact: Maggie H Shepherd, PhD Exeter +44 (0)1392 406772 email@example.com|
|Contact: Michelle M Hudson, BSc So'ton +44 (0)1392 406814 firstname.lastname@example.org|
|Principal Investigator: Andrew T Hattersley|
|Sub-Investigator: Margaret H Shepherd|
|Peninsula College of Medicine & Dentistry, University of Plymouth, John Bull Building, Tamar Science Park,||Not yet recruiting|
|Plymouth, Devon, United Kingdom, PL6 8BU|
|Contact: Beverley A Millward +44 (0)1752 437411 email@example.com|
|Principal Investigator: Beverley A Millward|
|Biomedical Research Institute, University of Dundee,||Recruiting|
|Dundee, United Kingdom, DD1 9SY|
|Contact: Ewan R Pearson, PhD Exeter +44 (0)1382 740081 firstname.lastname@example.org|
|Principal Investigator: Ewan R Pearson|
|Principal Investigator:||Andrew T Hattersley||Peninsula NIHR Clinical Research Facility, Peninsula Medical School, University of Exeter, Barrack Rd, Exeter, EX2 5DW|