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 : March 19, 2019
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Condition or disease | Intervention/treatment |
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Diabetes | Other: patient care pathway |

Study Type : | Observational |
Actual Enrollment : | 1916 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Diabetes diagnosed under 30 years
Patients currently under 50 years of age diagnosed with diabetes under 30 years.
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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. |
- 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.
- 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.
- 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

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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 |
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

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 |
Principal Investigator: | Andrew T Hattersley | Peninsula NIHR Clinical Research Facility, Peninsula Medical School, University of Exeter, Barrack Rd, Exeter, EX2 5DW |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Exeter |
ClinicalTrials.gov Identifier: | NCT01238380 |
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: | March 19, 2019 |
Last Verified: | March 2019 |
Monogenic diabetes HNF1A HNF4A |
GCK genetic testing health economic model |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |