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Lookup NU author(s): Dr Ana Viñuela Rodriguez, Dr Alison Heggie, Emeritus Professor Mark Walker
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2019, The Author(s). Aims/hypothesis: Here, we describe the characteristics of the Innovative Medicines Initiative (IMI) Diabetes Research on Patient Stratification (DIRECT) epidemiological cohorts at baseline and follow-up examinations (18, 36 and 48 months of follow-up). Methods: From a sampling frame of 24,682 adults of European ancestry enrolled in population-based cohorts across Europe, participants at varying risk of glycaemic deterioration were identified using a risk prediction algorithm (based on age, BMI, waist circumference, use of antihypertensive medication, smoking status and parental history of type 2 diabetes) and enrolled into a prospective cohort study (n = 2127) (cohort 1, prediabetes risk). We also recruited people from clinical registries with type 2 diabetes diagnosed 6–24 months previously (n = 789) into a second cohort study (cohort 2, diabetes). Follow-up examinations took place at ~18 months (both cohorts) and at ~48 months (cohort 1) or ~36 months (cohort 2) after baseline examinations. The cohorts were studied in parallel using matched protocols across seven clinical centres in northern Europe. Results: Using ADA 2011 glycaemic categories, 33% (n = 693) of cohort 1 (prediabetes risk) had normal glucose regulation and 67% (n = 1419) had impaired glucose regulation. Seventy-six per cent of participants in cohort 1 was male. Cohort 1 participants had the following characteristics (mean ± SD) at baseline: age 62 (6.2) years; BMI 27.9 (4.0) kg/m2; fasting glucose 5.7 (0.6) mmol/l; 2 h glucose 5.9 (1.6) mmol/l. At the final follow-up examination the participants’ clinical characteristics were as follows: fasting glucose 6.0 (0.6) mmol/l; 2 h OGTT glucose 6.5 (2.0) mmol/l. In cohort 2 (diabetes), 66% (n = 517) were treated by lifestyle modification and 34% (n = 272) were treated with metformin plus lifestyle modification at enrolment. Fifty-eight per cent of participants in cohort 2 was male. Cohort 2 participants had the following characteristics at baseline: age 62 (8.1) years; BMI 30.5 (5.0) kg/m2; fasting glucose 7.2 (1.4) mmol/l; 2 h glucose 8.6 (2.8) mmol/l. At the final follow-up examination, the participants’ clinical characteristics were as follows: fasting glucose 7.9 (2.0) mmol/l; 2 h mixed-meal tolerance test glucose 9.9 (3.4) mmol/l. Conclusions/interpretation: The IMI DIRECT cohorts are intensely characterised, with a wide-variety of metabolically relevant measures assessed prospectively. We anticipate that the cohorts, made available through managed access, will provide a powerful resource for biomarker discovery, multivariate aetiological analyses and reclassification of patients for the prevention and treatment of type 2 diabetes.
Author(s): Koivula RW, Forgie IM, Kurbasic A, Vinuela A, Heggie A, Giordano GN, Hansen TH, Hudson M, Koopman ADM, Rutters F, Siloaho M, Allin KH, Brage S, Brorsson CA, Dawed AY, De Masi F, Groves CJ, Kokkola T, Mahajan A, Perry MH, Rauh SP, Ridderstrale M, Teare HJA, Thomas EL, Tura A, Vestergaard H, White T, Adamski J, Bell JD, Beulens JW, Brunak S, Dermitzakis ET, Froguel P, Frost G, Gupta R, Hansen T, Hattersley A, Jablonka B, Kaye J, Laakso M, McDonald TJ, Pedersen O, Schwenk JM, Pavo I, Mari A, McCarthy MI, Ruetten H, Walker M, Pearson E, Franks PW
Publication type: Article
Publication status: Published
Journal: Diabetologia
Year: 2019
Volume: 62
Issue: 9
Pages: 1601-1615
Print publication date: 01/09/2019
Online publication date: 15/06/2019
Acceptance date: 10/04/2019
Date deposited: 24/10/2024
ISSN (print): 0012-186X
ISSN (electronic): 1432-0428
Publisher: Springer Verlag
URL: https://doi.org/10.1007/s00125-019-4906-1
DOI: 10.1007/s00125-019-4906-1
Data Access Statement: Requests for access to IMI DIRECT data, including data presented here, can made to DIRECTdataaccess@Dundee.ac.uk.
PubMed id: 31203377
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