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

Abstract

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

Metformin and aspirin treatment could lead to an improved survival rate for Type 2 diabetic patients with stage II and III colorectal adenocarcinoma relative to non-diabetic patients

“…In the present study cardiovascular diseases, malignancies other than CRC and chronic kidney diseases are the most frequent comorbidities in DM2 patients in agreement with other studies (28,29). Diabetes mellitus is, indeed, a major risk factor for cardiovascular diseases, whose prevalence is twice as high in males and even four times more frequent in females (30).…”

A Prospective Cohort Study in Patients with Type 2 Diabetes Mellitus for Validation of Biomarkers (PROVALID) – Study Design and Baseline Characteristics

“…Next to the French SURDIAGENE study [17]. the German DIACORE project is another ongoing project with similarities to PROVALID [18]. However, DIACORE not only focuses on renal complications but rather aims to elucidate mechanisms involved in the development and progression of all type 2 diabetes mellitus associated complications.…”

Progression chronischer Nierenerkrankungen

“…Von einer in Planung befindlichen GWAS-Metaanalyse von mehr als 100.000 Individuen mit einem neuen, hochauflösenden genetischen Datensatz verspricht man sich wichtige neue Erkenntnisse in der Genetik für Nierenfunktionsverlustphänotypen. In der Zukunft werden auch GWAS in Risikokollektiven durchgeführt, die das genetische Progressionsrisiko bei Patienten mit manifester CKD analysieren [15][16][17].…”