NCT01238380|CompletedDMC
Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
UNITED
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UNITED
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Wellcome Trust and Department of Health
observational
1,916
1 country
3
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2010
Actual (reported)November 10, 2010
Actual (reported)December 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)September 2013
Actual (reported)Identification of patients with monogenic diabetes
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.
Within 4 years from start of project
To examine the impact of making a diagnosis of monogenic diabetes on patients' treatment, glucose control and quality of life.
Within 4 years of the project start date.
To develop a health economic model of the care pathway leading to testing of monogenic diabetes.
Within 4 years of the project start date.
Patients currently under 50 years of age diagnosed with diabetes under 30 years.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients currently under the age of 50 years, diagnosed under the age of 30years, from South-West England and Tayside, Scotland, UK.
Peninsula NIHR Clinical Research Facility, Peninsula Medical School, Barrack Rd,
Exeter, Devon, EX2 5DW, United Kingdom
Peninsula College of Medicine & Dentistry, University of Plymouth, John Bull Building, Tamar Science Park,
Plymouth, Devon, PL6 8BU, United Kingdom
Biomedical Research Institute, University of Dundee,
Dundee, DD1 9SY, United Kingdom
Shields BM, Hicks S, Shepherd MH, Colclough K, Hattersley AT, Ellard S. Maturity-onset diabetes of the young (MODY): how many cases are we missing? Diabetologia. 2010 Dec;53(12):2504-8. doi: 10.1007/s00125-010-1799-4. Epub 2010 May 25.
McDonald TJ, Knight BA, Shields BM, Bowman P, Salzmann MB, Hattersley AT. Stability and reproducibility of a single-sample urinary C-peptide/creatinine ratio and its correlation with 24-h urinary C-peptide. Clin Chem. 2009 Nov;55(11):2035-9. doi: 10.1373/clinchem.2009.129312. Epub 2009 Aug 27.
Samples with DNA and plasma samples.
Andrew T Hattersley
Peninsula NIHR Clinical Research Facility, Peninsula Medical School, University of Exeter, Barrack Rd, Exeter, EX2 5DW
1,916 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2010
First Posted
November 10, 2010
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Physical Activity Advice in Diabetics at Annual Review
Contact the study team to confirm eligibility.
Shepherd M, Shields B, Ellard S, Rubio-Cabezas O, Hattersley AT. A genetic diagnosis of HNF1A diabetes alters treatment and improves glycaemic control in the majority of insulin-treated patients. Diabet Med. 2009 Apr;26(4):437-41. doi: 10.1111/j.1464-5491.2009.02690.x.
Ellard S, Bellanne-Chantelot C, Hattersley AT; European Molecular Genetics Quality Network (EMQN) MODY group. Best practice guidelines for the molecular genetic diagnosis of maturity-onset diabetes of the young. Diabetologia. 2008 Apr;51(4):546-53. doi: 10.1007/s00125-008-0942-y. Epub 2008 Feb 23.
Pearson ER, Pruhova S, Tack CJ, Johansen A, Castleden HA, Lumb PJ, Wierzbicki AS, Clark PM, Lebl J, Pedersen O, Ellard S, Hansen T, Hattersley AT. Molecular genetics and phenotypic characteristics of MODY caused by hepatocyte nuclear factor 4alpha mutations in a large European collection. Diabetologia. 2005 May;48(5):878-85. doi: 10.1007/s00125-005-1738-y. Epub 2005 Apr 14.
Pearson ER, Starkey BJ, Powell RJ, Gribble FM, Clark PM, Hattersley AT. Genetic cause of hyperglycaemia and response to treatment in diabetes. Lancet. 2003 Oct 18;362(9392):1275-81. doi: 10.1016/S0140-6736(03)14571-0.
Grace SL, Cooper A, Jones AG, McDonald TJ. Zinc transporter 8 autoantibody testing requires age-related cut-offs. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002296. doi: 10.1136/bmjdrc-2021-002296.
Peters JL, Anderson R, Shields B, King S, Hudson M, Shepherd M, McDonald TJ, Pearson E, Hattersley A, Hyde C. Strategies to identify individuals with monogenic diabetes: results of an economic evaluation. BMJ Open. 2020 Mar 18;10(3):e034716. doi: 10.1136/bmjopen-2019-034716.
Shields BM, Shepherd M, Hudson M, McDonald TJ, Colclough K, Peters J, Knight B, Hyde C, Ellard S, Pearson ER, Hattersley AT; UNITED study team. Population-Based Assessment of a Biomarker-Based Screening Pathway to Aid Diagnosis of Monogenic Diabetes in Young-Onset Patients. Diabetes Care. 2017 Aug;40(8):1017-1025. doi: 10.2337/dc17-0224.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
March 19, 2019
Record last verified: 2019-03
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