Clinical trial NCT02783469: Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)
Official title: Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathic Pain
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Diabetes UK
First posted: 2016-05-26
Enrollment: 1915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients and non-diabetic controls will be recruited from residents of the Tayside area of Scotland (n=411,749 according to SCI-Diabetes).

Brief summary: In 1997, the global prevalence of diabetes was estimated to be 125 million and this has risen to around 400 million in 2015. In addition diabetes has a number of complications including heart disease, blindness, kidney failure and amputation. This represents a significant burden on healthcare services. Type 2 diabetes (T2D) is caused by a combination of genetic and environmental factors. The aim of GoDARTS is to recruit participants with T2D to a registry to provide a platform with which to investigate the genetics of T2D, its complications and response to treatment. This study will investigate the genetic basis of diabetic neuropathic pain.

Detailed description: GoDARTS is the genetics arm of the DARTS study, which was set up to identify all diabetes patients in the Tayside region. Its aim is to improve diabetes care over and above existing practices. Participants are invited to attend to provide blood samples for DNA/RNA analysis, provide baseline anthropometric, biochemical, blood pressure and heart rate measurements as well as completing a lifestyle questionnaire containing smoking, menopausal and physical activity items. Consent is also obtained to allow anonymous linkage to electronic medical records (EMR) through use of the Community Health Index (CHI) number, a unique patient identifier that is issued to everyone registered with a general practitioner in Scotland. GoDARTS is the first EMR linked cohort in the world and provides access to individual participant longitudinal data including biochemical, comorbidity and prescription records. These are live databases and are constantly being updated. This allows for the study of genetic factors influencing T2D, its comorbidities and response to therapy. Consent has also been obtained for re-contact by collaborators, allowing for further studies of related phenotypes to take place. One of these studies is DOLORisk Dundee which aims to identify genetic and environmental risk factors for neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* Previous participation with GoDARTS
* Existing consent to be recontacted
* Identified as being currently alive
* Currently has a postal address
* age \> 18 years
* Neuropathic

Exclusion Criteria:

* Unable to give consent
* No current postcode
* Identified as having died

Primary outcomes:
measure: Neuropathic Pain
timeFrame: April 2016 - December 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
Study officials:
affiliation: University of Dundee
name: Colin Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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