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

This study has been completed.
Sponsor:
Collaborators:
University of Exeter
University of Dundee
Wellcome Trust
Department of Health, United Kingdom
Information provided by (Responsible Party):
NIHR Exeter Clinical Research Facility
ClinicalTrials.gov Identifier:
NCT01238380
First received: November 9, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention
Diabetes
Other: patient care pathway

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes

Resource links provided by NLM:


Further study details as provided by NIHR Exeter Clinical Research Facility:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1916
Study Start Date: December 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238380

Locations
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
Investigators
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:
Publications:

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
Study First Received: November 9, 2010
Last Updated: April 2, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NIHR Exeter Clinical Research Facility:
Monogenic diabetes
HNF1A
HNF4A
GCK
genetic testing
health economic model

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

ClinicalTrials.gov processed this record on August 01, 2014