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Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes

NCT01238380 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1916

Last updated 2019-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Dundee

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Department of Health, United Kingdom

    collaborator OTHER_GOV

  • University of Exeter

    lead OTHER

Principal Investigators

  • Andrew T Hattersley · Peninsula NIHR Clinical Research Facility, Peninsula Medical School, University of Exeter, Barrack Rd, Exeter, EX2 5DW

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01238380 on ClinicalTrials.gov