Diabetic Neuropathic Pain
Conditions
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.
Interventions
GENETICIdentification of genetic causes of diabetic neuropathic pain
Sponsors
Wellcome Trust
Diabetes UK
University of Dundee
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain | April 2016 - December 2016 | Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language) |
Countries
United Kingdom
Participant flow
Recruitment details
At baseline recruitment, participants of GoDARTS who had provided consent to be contacted about related studies, were sent and invited to complete and return a DOLORisk Dundee questionnaire on neuropathic pain and pain-related traits, between December 2016. Approximately 18 months later, participants of the baseline survey who provided further consent to be recontacted, were sent a similar follow-up questionnaire.
Participants by arm
| Arm | Count |
|---|---|
| GoDARTS Participants of the DOLORisk Dundee baseline survey | 1,915 |
| Total | 1,915 |
Baseline characteristics
| Characteristic | GoDARTS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1421 Participants |
| Age, Categorical Between 18 and 65 years | 491 Participants |
| Age, Continuous | 71 years |
| Douleur Neuropathique en Quatre Questions (DN4) DN4 < 3 | 527 Participants |
| Douleur Neuropathique en Quatre Questions (DN4) DN4 ≥ 3 | 348 Participants |
| Pain Duration Duration < 3 months | 94 Participants |
| Pain Duration Duration ≥ 3 months | 1144 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 1904 Participants |
| Sex: Female, Male Female | 754 Participants |
| Sex: Female, Male Male | 1158 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,915 |
| serious Total, serious adverse events | 0 / 1,915 |
Outcome results
Primary
Neuropathic Pain
Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)
Time frame: April 2016 - December 2016
Population: Chronic neuropathic pain = DN4 ≥ 3 \& pain duration ≥ 3 months Chronic nociceptive pain = DN4 \< 3 \& pain duration ≥ 3 months No pain = no current pain or currently taking pain medication~Note: Participants were included in the chronic neuropathic pain group if they satisfied the above criteria, regardless of the number of missing DN4 items, and excluded from the chronic nociceptive pain group if the number of missing DN4 items plus the their DN4 score totalled 3 or more.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GoDARTS | Neuropathic Pain | Chronic Neuropathic Pain | 482 Participants |
| GoDARTS | Neuropathic Pain | Chronic Nociceptive Pain | 461 Participants |
| GoDARTS | Neuropathic Pain | No Pain | 560 Participants |