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Open Access Highly Accessed Study protocol

Study design of DIACORE (DIAbetes COhoRtE) – a cohort study of patients with diabetes mellitus type 2

Lena Dörhöfer1, Alexander Lammert2, Vera Krane3, Mathias Gorski14, Bernhard Banas1, Christoph Wanner3, Bernhard K Krämer2, Iris M Heid45, Carsten A Böger1* and for the DIACORE Study Group

Author Affiliations

1 Department of Internal Medicine II, Nephrology, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93042, Regensburg, Germany

2 Department of Medicine, Nephrology, Endocrinology, Diabetology, Rheumatology; Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor Kutzer Ufer 1-3, 68167, Mannheim, Germany

3 Department of Internal Medicine I, Division of Nephrology, University Hospital Würzburg, Oberdürrbacherstraße 6, 97080, Würzburg, Germany

4 Genetic Epidemiology, Department of Epidemiology and Preventive Medicine, University Regensburg, Franz-Josef-Strauß-Allee 11, 93042, Regensburg, Germany

5 Institute of Genetic Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Ingolstädter Landstr. 1, 85764, Neuherberg, Germany

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BMC Medical Genetics 2013, 14:25  doi:10.1186/1471-2350-14-25

Published: 14 February 2013

Abstract

Background

Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE).

Methods

DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro- and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e.g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness.

Discussion

DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies.

Keywords:
Diabetes mellitus type 2; Diabetic nephropathy; Chronic kidney disease; End stage renal disease; Cardiovascular morbidity; diabetes complications; Epidemiology; Genetics