Genetics of Diabetes Audit and Research in Tayside and Scotland
Research type
Research Study
Full title
Genetics of Diabetes Audit and Research in Tayside and Scotland
IRAS ID
199855
Contact name
Louise Greig
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet the planned inclusion criteria. The study aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. The study will specifically target patients who have been diagnosed within the past 2 years and follow up will be by linkage to electronic health record data. Up to 6,000 patients will be recruited into the study over a period of 2-3 years with a primary aim to identify 1000 of these patients who should be suitable to be started on metformin therapy.
Most patients will undergo a single screening visit lasting approximately 20 minutes conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend a second clinic visit to be carried out between 4-6 months after initiation of metformin therapy.
Up to 9 health boards will be approached regarding participating in the study, and it is estimated that between 4-6 diabetes patients will be recruited into the study each week, at each site.
All screened patients will provide consent for data linkage and longitudinal follow up and their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection into the resource will be managed by the co-ordinating centre study team based at the University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository and access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
16/ES/0025
Date of REC Opinion
11 Apr 2016
REC opinion
Further Information Favourable Opinion