Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes (UNITED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01238380|
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : April 4, 2014
|Condition or disease||Intervention/treatment|
|Diabetes||Other: patient care pathway|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1916 participants|
|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|
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.
- 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
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
|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|