Diabetic Neuropathic PainGoDARTSNCT02783469
Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)
An observational study of Diabetic Neuropathic Pain, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathic Pain
- What is being tested?
- Identification of genetic causes of diabetic neuropathic pain
- How many people
- 1,915 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2004to 31 May 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Previous participation with GoDARTS
- Existing consent to be recontacted
- Identified as being currently alive
- Currently has a postal address
- age > 18 years
- Neuropathic
Who cannot join
- Unable to give consent
- No current postcode
- Identified as having died
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathic Pain
- Being tested
- Identification of genetic causes of diabetic neuropathic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of genetic causes of diabetic neuropathic painGenetic
| Study group | Role | What they receive |
|---|---|---|
| Diabetic neuropathic pain | Those with type 2 diabetes and painful neuropathy Receives: Genetic: Identification of genetic causes of diabetic neuropathic pain | |
| Controls | Type 2 diabetics with non-painful neuropathy, or pain without neuropathy Receives: Genetic: Identification of genetic causes of diabetic neuropathic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain
Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)
Measured: April 2016 - December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startOct 2004
- Primary completion31 May 2009
- Study completion31 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,915 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Diabetes UK
- Responsible party
- Sponsor
- Investigators
- Colin Palmer, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783469
- Sponsor's protocol ID
- 2003DM08
- Acronym
- GoDARTS
- Status last verified
- Jul 2021
- First submitted
- 12 Apr 2016
- Last updated
- 16 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Morris AD, Boyle DI, MacAlpine R, Emslie-Smith A, Jung RT, Newton RW, MacDonald TM. The diabetes audit and research in Tayside Scotland (DARTS) study: electronic record linkage to create a diabetes register. DARTS/MEMO Collaboration. BMJ. 1997 Aug 30;315(7107):524-8. doi: 10.1136/bmj.315.7107.524.
PubMed 9329309Dujic T, Zhou K, Donnelly LA, Tavendale R, Palmer CN, Pearson ER. Association of Organic Cation Transporter 1 With Intolerance to Metformin in Type 2 Diabetes: A GoDARTS Study. Diabetes. 2015 May;64(5):1786-93. doi: 10.2337/db14-1388. Epub 2014 Dec 15.
PubMed 25510240Looker HC, Colombo M, Hess S, Brosnan MJ, Farran B, Dalton RN, Wong MC, Turner C, Palmer CN, Nogoceke E, Groop L, Salomaa V, Dunger DB, Agakov F, McKeigue PM, Colhoun HM; SUMMIT Investigators. Biomarkers of rapid chronic kidney disease progression in type 2 diabetes. Kidney Int. 2015 Oct;88(4):888-96. doi: 10.1038/ki.2015.199. Epub 2015 Jul 22.
PubMed 26200946Mahajan A, Sim X, Ng HJ, Manning A, Rivas MA, Highland HM, Locke AE, Grarup N, Im HK, Cingolani P, Flannick J, Fontanillas P, Fuchsberger C, Gaulton KJ, Teslovich TM, Rayner NW, Robertson NR, Beer NL, Rundle JK, Bork-Jensen J, Ladenvall C, Blancher C, Buck D, Buck G, Burtt NP, Gabriel S, Gjesing AP, Groves CJ, Hollensted M, Huyghe JR, Jackson AU, Jun G, Justesen JM, Mangino M, Murphy J, Neville M, Onofrio R, Small KS, Stringham HM, Syvanen AC, Trakalo J, Abecasis G, Bell GI, Blangero J, Cox NJ, Duggirala R, Hanis CL, Seielstad M, Wilson JG, Christensen C, Brandslund I, Rauramaa R, Surdulescu GL, Doney AS, Lannfelt L, Linneberg A, Isomaa B, Tuomi T, Jorgensen ME, Jorgensen T, Kuusisto J, Uusitupa M, Salomaa V, Spector TD, Morris AD, Palmer CN, Collins FS, Mohlke KL, Bergman RN, Ingelsson E, Lind L, Tuomilehto J, Hansen T, Watanabe RM, Prokopenko I, Dupuis J, Karpe F, Groop L, Laakso M, Pedersen O, Florez JC, Morris AP, Altshuler D, Meigs JB, Boehnke M, McCarthy MI, Lindgren CM, Gloyn AL; T2D-GENES consortium and GoT2D consortium. Identification and functional characterization of G6PC2 coding variants influencing glycemic traits define an effector transcript at the G6PC2-ABCB11 locus. PLoS Genet. 2015 Jan 27;11(1):e1004876. doi: 10.1371/journal.pgen.1004876. eCollection 2015 Jan.
PubMed 25625282Meng W, Deshmukh HA, Donnelly LA; Wellcome Trust Case Control Consortium 2 (WTCCC2); Surrogate markers for Micro- and Macro-vascular hard endpoints for Innovative diabetes Tools (SUMMIT) study group; Torrance N, Colhoun HM, Palmer CN, Smith BH. A Genome-wide Association Study Provides Evidence of Sex-specific Involvement of Chr1p35.1 (ZSCAN20-TLR12P) and Chr8p23.1 (HMGB1P46) With Diabetic Neuropathic Pain. EBioMedicine. 2015 Aug 4;2(10):1386-93. doi: 10.1016/j.ebiom.2015.08.001. eCollection 2015 Oct.
PubMed 26629533Meng W, Deshmukh HA, van Zuydam NR, Liu Y, Donnelly LA, Zhou K; Wellcome Trust Case Control Consortium 2 (WTCCC2); Surrogate Markers for Micro- and Macro-Vascular Hard Endpoints for Innovative Diabetes Tools (SUMMIT) Study Group; Morris AD, Colhoun HM, Palmer CN, Smith BH. A genome-wide association study suggests an association of Chr8p21.3 (GFRA2) with diabetic neuropathic pain. Eur J Pain. 2015 Mar;19(3):392-9. doi: 10.1002/ejp.560.
PubMed 24974787Mosley JD, Shaffer CM, Van Driest SL, Weeke PE, Wells QS, Karnes JH, Velez Edwards DR, Wei WQ, Teixeira PL, Bastarache L, Crawford DC, Li R, Manolio TA, Bottinger EP, McCarty CA, Linneman JG, Brilliant MH, Pacheco JA, Thompson W, Chisholm RL, Jarvik GP, Crosslin DR, Carrell DS, Baldwin E, Ralston J, Larson EB, Grafton J, Scrol A, Jouni H, Kullo IJ, Tromp G, Borthwick KM, Kuivaniemi H, Carey DJ, Ritchie MD, Bradford Y, Verma SS, Chute CG, Veluchamy A, Siddiqui MK, Palmer CN, Doney A, MahmoudPour SH, Maitland-van der Zee AH, Morris AD, Denny JC, Roden DM. A genome-wide association study identifies variants in KCNIP4 associated with ACE inhibitor-induced cough. Pharmacogenomics J. 2016 Jun;16(3):231-7. doi: 10.1038/tpj.2015.51. Epub 2015 Jul 14.
PubMed 26169577Postmus I, Trompet S, Deshmukh HA, Barnes MR, Li X, Warren HR, Chasman DI, Zhou K, Arsenault BJ, Donnelly LA, Wiggins KL, Avery CL, Griffin P, Feng Q, Taylor KD, Li G, Evans DS, Smith AV, de Keyser CE, Johnson AD, de Craen AJ, Stott DJ, Buckley BM, Ford I, Westendorp RG, Slagboom PE, Sattar N, Munroe PB, Sever P, Poulter N, Stanton A, Shields DC, O'Brien E, Shaw-Hawkins S, Chen YD, Nickerson DA, Smith JD, Dube MP, Boekholdt SM, Hovingh GK, Kastelein JJ, McKeigue PM, Betteridge J, Neil A, Durrington PN, Doney A, Carr F, Morris A, McCarthy MI, Groop L, Ahlqvist E; Welcome Trust Case Control Consortium; Bis JC, Rice K, Smith NL, Lumley T, Whitsel EA, Sturmer T, Boerwinkle E, Ngwa JS, O'Donnell CJ, Vasan RS, Wei WQ, Wilke RA, Liu CT, Sun F, Guo X, Heckbert SR, Post W, Sotoodehnia N, Arnold AM, Stafford JM, Ding J, Herrington DM, Kritchevsky SB, Eiriksdottir G, Launer LJ, Harris TB, Chu AY, Giulianini F, MacFadyen JG, Barratt BJ, Nyberg F, Stricker BH, Uitterlinden AG, Hofman A, Rivadeneira F, Emilsson V, Franco OH, Ridker PM, Gudnason V, Liu Y, Denny JC, Ballantyne CM, Rotter JI, Adrienne Cupples L, Psaty BM, Palmer CN, Tardif JC, Colhoun HM, Hitman G, Krauss RM, Wouter Jukema J, Caulfield MJ. Pharmacogenetic meta-analysis of genome-wide association studies of LDL cholesterol response to statins. Nat Commun. 2014 Oct 28;5:5068. doi: 10.1038/ncomms6068.
PubMed 25350695Zhou K, Donnelly L, Yang J, Li M, Deshmukh H, Van Zuydam N, Ahlqvist E; Wellcome Trust Case Control Consortium 2; Spencer CC, Groop L, Morris AD, Colhoun HM, Sham PC, McCarthy MI, Palmer CN, Pearson ER. Heritability of variation in glycaemic response to metformin: a genome-wide complex trait analysis. Lancet Diabetes Endocrinol. 2014 Jun;2(6):481-7. doi: 10.1016/S2213-8587(14)70050-6. Epub 2014 Mar 19.
PubMed 24731673Alkayyali S, Lajer M, Deshmukh H, Ahlqvist E, Colhoun H, Isomaa B, Rossing P, Groop L, Lyssenko V. Common variant in the HMGA2 gene increases susceptibility to nephropathy in patients with type 2 diabetes. Diabetologia. 2013 Feb;56(2):323-9. doi: 10.1007/s00125-012-2760-5. Epub 2012 Oct 31.
PubMed 23111731Deshmukh HA, Palmer CN, Morris AD, Colhoun HM. Investigation of known estimated glomerular filtration rate loci in patients with type 2 diabetes. Diabet Med. 2013 Oct;30(10):1230-5. doi: 10.1111/dme.12211. Epub 2013 May 14.
PubMed 23586973Donnelly LA, van Zuydam NR, Zhou K, Tavendale R, Carr F, Maitland-van der Zee AH, Leusink M, de Boer A, Doevendans PA, Asselbergs FW, Morris AD, Pearson ER, Klungel OH, Doney AS, Palmer CN. Robust association of the LPA locus with low-density lipoprotein cholesterol lowering response to statin treatment in a meta-analysis of 30 467 individuals from both randomized control trials and observational studies and association with coronary artery disease outcome during statin treatment. Pharmacogenet Genomics. 2013 Oct;23(10):518-25. doi: 10.1097/FPC.0b013e3283642fd6.
PubMed 23903772Liu Y, Wang M, Morris AD, Doney AS, Leese GP, Pearson ER, Palmer CN. Glycemic exposure and blood pressure influencing progression and remission of diabetic retinopathy: a longitudinal cohort study in GoDARTS. Diabetes Care. 2013 Dec;36(12):3979-84. doi: 10.2337/dc12-2392. Epub 2013 Oct 29.
PubMed 24170761Parry HM, Donnelly LA, Van Zuydam N, Doney AS, Elder DH, Morris AD, Struthers AD, Palmer CN, Lang CC; Wellcome Trust Case Control Consortium 2. Genetic variants predicting left ventricular hypertrophy in a diabetic population: a Go-DARTS study including meta-analysis. Cardiovasc Diabetol. 2013 Jul 23;12:109. doi: 10.1186/1475-2840-12-109.
PubMed 23879873Palmer CN, Maglio C, Pirazzi C, Burza MA, Adiels M, Burch L, Donnelly LA, Colhoun H, Doney AS, Dillon JF, Pearson ER, McCarthy M, Hattersley AT, Frayling T, Morris AD, Peltonen M, Svensson PA, Jacobson P, Boren J, Sjostrom L, Carlsson LM, Romeo S. Paradoxical lower serum triglyceride levels and higher type 2 diabetes mellitus susceptibility in obese individuals with the PNPLA3 148M variant. PLoS One. 2012;7(6):e39362. doi: 10.1371/journal.pone.0039362. Epub 2012 Jun 18.
PubMed 22724004
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)
- ClinicalTrials.gov ID
- NCT02783469
- Acronym / sponsor ID
- GoDARTS / 2003DM08
- Conditions
- Diabetic Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,915 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Wellcome Trust, Diabetes UK
- Study start
- Oct 2004 (actual)
- Primary completion
- 31 May 2009 (actual)
- Study completion
- 31 May 2009 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic neuropathic pain | – | Genetic: Identification of genetic causes of diabetic neuropathic painThose with type 2 diabetes and painful neuropathy |
| Controls | – | Genetic: Identification of genetic causes of diabetic neuropathic painType 2 diabetics with non-painful neuropathy, or pain without neuropathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- Previous participation with GoDARTS
- Existing consent to be recontacted
- Identified as being currently alive
- Currently has a postal address
- age > 18 years
Key exclusion criteria (3 listed)
- Unable to give consent
- No current postcode
- Identified as having died
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of genetic causes of diabetic neuropathic pain | Genetic | Controls, Diabetic neuropathic pain |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9329309Morris AD, Boyle DI, MacAlpine R, Emslie-Smith A, Jung RT, Newton RW, MacDonald TM. The diabetes audit and research in Tayside Scotland (DARTS) study: electronic record linkage to create a diabetes register. DARTS/MEMO Collaboration. BMJ. 1997 Aug 30;315(7107):524-8. doi: 10.1136/bmj.315.7107.524.
- Results publication: PubMed 25510240Dujic T, Zhou K, Donnelly LA, Tavendale R, Palmer CN, Pearson ER. Association of Organic Cation Transporter 1 With Intolerance to Metformin in Type 2 Diabetes: A GoDARTS Study. Diabetes. 2015 May;64(5):1786-93. doi: 10.2337/db14-1388. Epub 2014 Dec 15.
- Results publication: PubMed 26200946Looker HC, Colombo M, Hess S, Brosnan MJ, Farran B, Dalton RN, Wong MC, Turner C, Palmer CN, Nogoceke E, Groop L, Salomaa V, Dunger DB, Agakov F, McKeigue PM, Colhoun HM; SUMMIT Investigators. Biomarkers of rapid chronic kidney disease progression in type 2 diabetes. Kidney Int. 2015 Oct;88(4):888-96. doi: 10.1038/ki.2015.199. Epub 2015 Jul 22.
- Results publication: PubMed 25625282Mahajan A, Sim X, Ng HJ, Manning A, Rivas MA, Highland HM, Locke AE, Grarup N, Im HK, Cingolani P, Flannick J, Fontanillas P, Fuchsberger C, Gaulton KJ, Teslovich TM, Rayner NW, Robertson NR, Beer NL, Rundle JK, Bork-Jensen J, Ladenvall C, Blancher C, Buck D, Buck G, Burtt NP, Gabriel S, Gjesing AP, Groves CJ, Hollensted M, Huyghe JR, Jackson AU, Jun G, Justesen JM, Mangino M, Murphy J, Neville M, Onofrio R, Small KS, Stringham HM, Syvanen AC, Trakalo J, Abecasis G, Bell GI, Blangero J, Cox NJ, Duggirala R, Hanis CL, Seielstad M, Wilson JG, Christensen C, Brandslund I, Rauramaa R, Surdulescu GL, Doney AS, Lannfelt L, Linneberg A, Isomaa B, Tuomi T, Jorgensen ME, Jorgensen T, Kuusisto J, Uusitupa M, Salomaa V, Spector TD, Morris AD, Palmer CN, Collins FS, Mohlke KL, Bergman RN, Ingelsson E, Lind L, Tuomilehto J, Hansen T, Watanabe RM, Prokopenko I, Dupuis J, Karpe F, Groop L, Laakso M, Pedersen O, Florez JC, Morris AP, Altshuler D, Meigs JB, Boehnke M, McCarthy MI, Lindgren CM, Gloyn AL; T2D-GENES consortium and GoT2D consortium. Identification and functional characterization of G6PC2 coding variants influencing glycemic traits define an effector transcript at the G6PC2-ABCB11 locus. PLoS Genet. 2015 Jan 27;11(1):e1004876. doi: 10.1371/journal.pgen.1004876. eCollection 2015 Jan.
- Results publication: PubMed 26629533Meng W, Deshmukh HA, Donnelly LA; Wellcome Trust Case Control Consortium 2 (WTCCC2); Surrogate markers for Micro- and Macro-vascular hard endpoints for Innovative diabetes Tools (SUMMIT) study group; Torrance N, Colhoun HM, Palmer CN, Smith BH. A Genome-wide Association Study Provides Evidence of Sex-specific Involvement of Chr1p35.1 (ZSCAN20-TLR12P) and Chr8p23.1 (HMGB1P46) With Diabetic Neuropathic Pain. EBioMedicine. 2015 Aug 4;2(10):1386-93. doi: 10.1016/j.ebiom.2015.08.001. eCollection 2015 Oct.
- Results publication: PubMed 24974787Meng W, Deshmukh HA, van Zuydam NR, Liu Y, Donnelly LA, Zhou K; Wellcome Trust Case Control Consortium 2 (WTCCC2); Surrogate Markers for Micro- and Macro-Vascular Hard Endpoints for Innovative Diabetes Tools (SUMMIT) Study Group; Morris AD, Colhoun HM, Palmer CN, Smith BH. A genome-wide association study suggests an association of Chr8p21.3 (GFRA2) with diabetic neuropathic pain. Eur J Pain. 2015 Mar;19(3):392-9. doi: 10.1002/ejp.560.
- Results publication: PubMed 26169577Mosley JD, Shaffer CM, Van Driest SL, Weeke PE, Wells QS, Karnes JH, Velez Edwards DR, Wei WQ, Teixeira PL, Bastarache L, Crawford DC, Li R, Manolio TA, Bottinger EP, McCarty CA, Linneman JG, Brilliant MH, Pacheco JA, Thompson W, Chisholm RL, Jarvik GP, Crosslin DR, Carrell DS, Baldwin E, Ralston J, Larson EB, Grafton J, Scrol A, Jouni H, Kullo IJ, Tromp G, Borthwick KM, Kuivaniemi H, Carey DJ, Ritchie MD, Bradford Y, Verma SS, Chute CG, Veluchamy A, Siddiqui MK, Palmer CN, Doney A, MahmoudPour SH, Maitland-van der Zee AH, Morris AD, Denny JC, Roden DM. A genome-wide association study identifies variants in KCNIP4 associated with ACE inhibitor-induced cough. Pharmacogenomics J. 2016 Jun;16(3):231-7. doi: 10.1038/tpj.2015.51. Epub 2015 Jul 14.
- Results publication: PubMed 25350695Postmus I, Trompet S, Deshmukh HA, Barnes MR, Li X, Warren HR, Chasman DI, Zhou K, Arsenault BJ, Donnelly LA, Wiggins KL, Avery CL, Griffin P, Feng Q, Taylor KD, Li G, Evans DS, Smith AV, de Keyser CE, Johnson AD, de Craen AJ, Stott DJ, Buckley BM, Ford I, Westendorp RG, Slagboom PE, Sattar N, Munroe PB, Sever P, Poulter N, Stanton A, Shields DC, O'Brien E, Shaw-Hawkins S, Chen YD, Nickerson DA, Smith JD, Dube MP, Boekholdt SM, Hovingh GK, Kastelein JJ, McKeigue PM, Betteridge J, Neil A, Durrington PN, Doney A, Carr F, Morris A, McCarthy MI, Groop L, Ahlqvist E; Welcome Trust Case Control Consortium; Bis JC, Rice K, Smith NL, Lumley T, Whitsel EA, Sturmer T, Boerwinkle E, Ngwa JS, O'Donnell CJ, Vasan RS, Wei WQ, Wilke RA, Liu CT, Sun F, Guo X, Heckbert SR, Post W, Sotoodehnia N, Arnold AM, Stafford JM, Ding J, Herrington DM, Kritchevsky SB, Eiriksdottir G, Launer LJ, Harris TB, Chu AY, Giulianini F, MacFadyen JG, Barratt BJ, Nyberg F, Stricker BH, Uitterlinden AG, Hofman A, Rivadeneira F, Emilsson V, Franco OH, Ridker PM, Gudnason V, Liu Y, Denny JC, Ballantyne CM, Rotter JI, Adrienne Cupples L, Psaty BM, Palmer CN, Tardif JC, Colhoun HM, Hitman G, Krauss RM, Wouter Jukema J, Caulfield MJ. Pharmacogenetic meta-analysis of genome-wide association studies of LDL cholesterol response to statins. Nat Commun. 2014 Oct 28;5:5068. doi: 10.1038/ncomms6068.
- Results publication: PubMed 24731673Zhou K, Donnelly L, Yang J, Li M, Deshmukh H, Van Zuydam N, Ahlqvist E; Wellcome Trust Case Control Consortium 2; Spencer CC, Groop L, Morris AD, Colhoun HM, Sham PC, McCarthy MI, Palmer CN, Pearson ER. Heritability of variation in glycaemic response to metformin: a genome-wide complex trait analysis. Lancet Diabetes Endocrinol. 2014 Jun;2(6):481-7. doi: 10.1016/S2213-8587(14)70050-6. Epub 2014 Mar 19.
- Results publication: PubMed 23111731Alkayyali S, Lajer M, Deshmukh H, Ahlqvist E, Colhoun H, Isomaa B, Rossing P, Groop L, Lyssenko V. Common variant in the HMGA2 gene increases susceptibility to nephropathy in patients with type 2 diabetes. Diabetologia. 2013 Feb;56(2):323-9. doi: 10.1007/s00125-012-2760-5. Epub 2012 Oct 31.
- Results publication: PubMed 23586973Deshmukh HA, Palmer CN, Morris AD, Colhoun HM. Investigation of known estimated glomerular filtration rate loci in patients with type 2 diabetes. Diabet Med. 2013 Oct;30(10):1230-5. doi: 10.1111/dme.12211. Epub 2013 May 14.
- Results publication: PubMed 23903772Donnelly LA, van Zuydam NR, Zhou K, Tavendale R, Carr F, Maitland-van der Zee AH, Leusink M, de Boer A, Doevendans PA, Asselbergs FW, Morris AD, Pearson ER, Klungel OH, Doney AS, Palmer CN. Robust association of the LPA locus with low-density lipoprotein cholesterol lowering response to statin treatment in a meta-analysis of 30 467 individuals from both randomized control trials and observational studies and association with coronary artery disease outcome during statin treatment. Pharmacogenet Genomics. 2013 Oct;23(10):518-25. doi: 10.1097/FPC.0b013e3283642fd6.
- Individual participant dataSharing planned: Yes
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Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Palmer, PhD principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathic Pain, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain (time frame: April 2016 - December 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02783469, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.