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Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes (UNITED)

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ClinicalTrials.gov Identifier: NCT01238380
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : April 4, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Diabetes Other: patient care pathway

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 1916 participants
Time Perspective: Cross-Sectional
Official Title: Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
Study Start Date : December 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013
Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Identification of patients with monogenic diabetes [ Time Frame: Within 4 years from start of project ]
    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.

Secondary Outcome Measures :
  1. 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. ]

    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.

  2. 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. ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients currently under the age of 50 years, diagnosed under the age of 30years, from South-West England and Tayside, Scotland, UK.

Inclusion Criteria:

  • clinical diagnosis of diabetes
  • diagnosed under 30 years of ages
  • current age less than 50 years
  • willing and able to provide informed consent.

Exclusion Criteria:

  • age over 50 years
  • age at diagnosis over 30 years
  • adult with incapacity to consent
  • child with incapacity to assent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238380

United Kingdom
Peninsula NIHR Clinical Research Facility, Peninsula Medical School, Barrack Rd,
Exeter, Devon, United Kingdom, EX2 5DW
Peninsula College of Medicine & Dentistry, University of Plymouth, John Bull Building, Tamar Science Park,
Plymouth, Devon, United Kingdom, PL6 8BU
Biomedical Research Institute, University of Dundee,
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
NIHR Exeter Clinical Research Facility
University of Exeter
University of Dundee
Wellcome Trust
Department of Health, United Kingdom
Principal Investigator: Andrew T Hattersley Peninsula NIHR Clinical Research Facility, Peninsula Medical School, University of Exeter, Barrack Rd, Exeter, EX2 5DW
More Information

Additional Information:

Responsible Party: NIHR Exeter Clinical Research Facility
ClinicalTrials.gov Identifier: NCT01238380     History of Changes
Other Study ID Numbers: REC 10/H0106/63
HICF-1009-041 ( Other Grant/Funding Number: Wellcome Trust and Department of Health )
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014

Keywords provided by NIHR Exeter Clinical Research Facility:
Monogenic diabetes
genetic testing
health economic model

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases