Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)

Completed

• Conditions: Diabetic Neuropathic Pain
• Interventions: Genetic: Identification of genetic causes of diabetic neuropathic pain

• Registration Number: NCT02783469
• Lead Sponsor: University of Dundee

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.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2009-05-31
• Study Completion: 2009-05-31
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Results First Submitted: 2021-06-24
• Results First Submitted QC: 2021-06-24
• Status Verified: 2021-07
• Results First Posted: 2021-07-15
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1915

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic neuropathic pain	Identification of genetic causes of diabetic neuropathic pain	Those with type 2 diabetes and painful neuropathy
Controls	Identification of genetic causes of diabetic neuropathic pain	Type 2 diabetics with non-painful neuropathy, or pain without neuropathy

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain	April 2016 - December 2016	Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, United Kingdom