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

Diabetic Neuropathic Pain Clinical Trial

— GoDARTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783469
• Other study ID #: 2003DM08
• Status: Completed
• Start date: October 2004
• Est. completion date: May 31, 2009

Study information

• Verified date: July 2021
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1915
• Est. completion date: May 31, 2009
• Est. primary completion date: May 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathic Pain
• Neuralgia

Intervention

Genetic:
• Identification of genetic causes of diabetic neuropathic pain

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	Diabetes UK, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (35)

Alkayyali 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/ — View Citation

Deshmukh 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. — View Citation

Doney AS, Dannfald J, Kimber CH, Donnelly LA, Pearson E, Morris AD, Palmer CN. The FTO gene is associated with an atherogenic lipid profile and myocardial infarction in patients with type 2 diabetes: a Genetics of Diabetes Audit and Research Study in Tays — View Citation

Doney AS, Fischer B, Lee SP, Morris AD, Leese G, Palmer CN. Association of common variation in the PPARA gene with incident myocardial infarction in individuals with type 2 diabetes: a Go-DARTS study. Nucl Recept. 2005 Nov 25;3:4. — View Citation

Doney AS, Fischer B, Leese G, Morris AD, Palmer CN. Cardiovascular risk in type 2 diabetes is associated with variation at the PPARG locus: a Go-DARTS study. Arterioscler Thromb Vasc Biol. 2004 Dec;24(12):2403-7. Epub 2004 Oct 14. — View Citation

Doney AS, Lee S, Leese GP, Morris AD, Palmer CN. Increased cardiovascular morbidity and mortality in type 2 diabetes is associated with the glutathione S transferase theta-null genotype: a Go-DARTS study. Circulation. 2005 Jun 7;111(22):2927-34. Epub 2005 — View Citation

Doney AS, Leese GP, Olson J, Morris AD, Palmer CN. The Y402H variant of complement factor H is associated with age-related macular degeneration but not with diabetic retinal disease in the Go-DARTS study. Diabet Med. 2009 May;26(5):460-5. doi: 10.1111/j.1 — View Citation

Donnelly LA, Doney AS, Dannfald J, Whitley AL, Lang CC, Morris AD, Donnan PT, Palmer CN. A paucimorphic variant in the HMG-CoA reductase gene is associated with lipid-lowering response to statin treatment in diabetes: a GoDARTS study. Pharmacogenet Genomi — View Citation

Donnelly LA, Doney AS, Tavendale R, Lang CC, Pearson ER, Colhoun HM, McCarthy MI, Hattersley AT, Morris AD, Palmer CN. Common nonsynonymous substitutions in SLCO1B1 predispose to statin intolerance in routinely treated individuals with type 2 diabetes: a — View Citation

Donnelly LA, Palmer CN, Whitley AL, Lang CC, Doney AS, Morris AD, Donnan PT. Apolipoprotein E genotypes are associated with lipid-lowering responses to statin treatment in diabetes: a Go-DARTS study. Pharmacogenet Genomics. 2008 Apr;18(4):279-87. doi: 10. — View Citation

Donnelly 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 — View Citation

Dujic 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. — View Citation

GoDARTS and UKPDS Diabetes Pharmacogenetics Study Group; Wellcome Trust Case Control Consortium 2, Zhou K, Bellenguez C, Spencer CC, Bennett AJ, Coleman RL, Tavendale R, Hawley SA, Donnelly LA, Schofield C, Groves CJ, Burch L, Carr F, Strange A, Freeman C — View Citation

Grant RW, Wexler DJ. Loss-of-function CYP2C9 variants: finding the correct clinical role for Type 2 diabetes pharmacogenetic testing. Expert Rev Cardiovasc Ther. 2010 Mar;8(3):339-43. doi: 10.1586/erc.10.5. — View Citation

Gudmundsson J, Sulem P, Steinthorsdottir V, Bergthorsson JT, Thorleifsson G, Manolescu A, Rafnar T, Gudbjartsson D, Agnarsson BA, Baker A, Sigurdsson A, Benediktsdottir KR, Jakobsdottir M, Blondal T, Stacey SN, Helgason A, Gunnarsdottir S, Olafsdottir A, — View Citation

Kimber CH, Doney AS, Pearson ER, McCarthy MI, Hattersley AT, Leese GP, Morris AD, Palmer CN. TCF7L2 in the Go-DARTS study: evidence for a gene dose effect on both diabetes susceptibility and control of glucose levels. Diabetologia. 2007 Jun;50(6):1186-91. — View Citation

Liu 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: 1 — View Citation

Looker 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 — View Citation

Mahajan 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, Buc — View Citation

Meng 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-w — View Citation

Meng 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, Pa — View Citation

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. — View Citation

Mosley 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, C — View Citation

Palmer CN, Kimber CH, Doney AS, Proia AS, Morris AD, Gaetani E, Quarta M, Smith RC, Pola R. Combined effect of inflammatory gene polymorphisms and the risk of ischemic stroke in a prospective cohort of subjects with type 2 diabetes: a Go-DARTS study. Diab — View Citation

Palmer 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, Borén J, Sjöström L, Carlsson LM, Romeo S. Paradox — View Citation

Parry 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 m — View Citation

Pearson ER, Donnelly LA, Kimber C, Whitley A, Doney AS, McCarthy MI, Hattersley AT, Morris AD, Palmer CN. Variation in TCF7L2 influences therapeutic response to sulfonylureas: a GoDARTs study. Diabetes. 2007 Aug;56(8):2178-82. Epub 2007 May 22. — View Citation

Perry JR, Voight BF, Yengo L, Amin N, Dupuis J, Ganser M, Grallert H, Navarro P, Li M, Qi L, Steinthorsdottir V, Scott RA, Almgren P, Arking DE, Aulchenko Y, Balkau B, Benediktsson R, Bergman RN, Boerwinkle E, Bonnycastle L, Burtt NP, Campbell H, Charpent — View Citation

Postmus 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 — View Citation

Sandhu MS, Weedon MN, Fawcett KA, Wasson J, Debenham SL, Daly A, Lango H, Frayling TM, Neumann RJ, Sherva R, Blech I, Pharoah PD, Palmer CN, Kimber C, Tavendale R, Morris AD, McCarthy MI, Walker M, Hitman G, Glaser B, Permutt MA, Hattersley AT, Wareham NJ — View Citation

Vitart V, Rudan I, Hayward C, Gray NK, Floyd J, Palmer CN, Knott SA, Kolcic I, Polasek O, Graessler J, Wilson JF, Marinaki A, Riches PL, Shu X, Janicijevic B, Smolej-Narancic N, Gorgoni B, Morgan J, Campbell S, Biloglav Z, Barac-Lauc L, Pericic M, Klaric — View Citation

Warren LL, Li L, Nelson MR, Ehm MG, Shen J, Fraser DJ, Aponte JL, Nangle KL, Slater AJ, Woollard PM, Hall MD, Topp SD, Yuan X, Cardon LR, Chissoe SL, Mooser V, Morris AD, Palmer CN, Perry JR, Frayling TM, Whittaker JC, Waterworth DM. Deep resequencing unv — View Citation

Zhou K, Donnelly L, Burch L, Tavendale R, Doney AS, Leese G, Hattersley AT, McCarthy MI, Morris AD, Lang CC, Palmer CN, Pearson ER. Loss-of-function CYP2C9 variants improve therapeutic response to sulfonylureas in type 2 diabetes: a Go-DARTS study. Clin P — View Citation

Zhou 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 m — View Citation

Zhou K, Donnelly LA, Kimber CH, Donnan PT, Doney AS, Leese G, Hattersley AT, McCarthy MI, Morris AD, Palmer CN, Pearson ER. Reduced-function SLC22A1 polymorphisms encoding organic cation transporter 1 and glycemic response to metformin: a GoDARTS study. D — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic Pain	Neuropathic pain will be identified according to the validated Douleur Neuropathique en Quatre Questions (DN4) questionnaire (English language)	April 2016 - December 2016

External Links

•   Click here for more information about this study: "Genetics of Diabetes Audit and Research in Tayside Scotland" (GoDARTS)