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

July 15, 2021 updated by: University of Dundee
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

1915

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic neuropathic pain
Those with type 2 diabetes and painful neuropathy
Controls
Type 2 diabetics with non-painful neuropathy, or pain without neuropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain
Time Frame: April 2016 - December 2016
Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)
April 2016 - December 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Colin Palmer, PhD, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2004

Primary Completion (Actual)

May 31, 2009

Study Completion (Actual)

May 31, 2009

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathic Pain

Clinical Trials on Identification of genetic causes of diabetic neuropathic pain

Subscribe