Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2
Creators: name: Dörhöfer, Lena
name: Lammert, Alexander
name: Krane, Vera
name: Gorski, Mathias
name: Banas, Bernhard
name: Wanner, Christoph
name: Krämer, Bernhard K.
name: Heid, Iris M.
name: Böger, Carsten A.
Publisher: name: Universität Regensburg
Year: 2013
Subjects: subject: CHRONIC KIDNEY-DISEASE; STAGE RENAL-DISEASE; GENOME-WIDE ASSOCIATION; SERUM CREATININE; CARDIOVASCULAR-DISEASE; REPLACEMENT THERAPY; RISK-FACTORS; ALBUMINURIA; NEPHROPATHY; PROGRESSION; Diabetes mellitus type 2; Diabetic nephropathy; Chronic kidney disease; End stage renal disease; Cardiovascular morbidity; diabetes complications; Epidemiology; Genetics
subject: 610 Medizin
subject: Adolescent
subject: Adult
subject: Aged
subject: Aged, 80 and over
subject: Biological Specimen Banks
subject: Cardiovascular Diseases/etiology
subject: Cohort Studies
subject: Diabetes Mellitus, Type 2/ethnology
subject: Diabetic Nephropathies/ethnology
subject: European Continental Ancestry Group/ethnology
subject: Follow-Up Studies
subject: Germany/epidemiology
subject: Humans
subject: Kidney Failure, Chronic/etiology
subject: Middle Aged
subject: Phenotype
subject: Physical Examination
subject: Prospective Studies
subject: Renal Insufficiency, Chronic/etiology
subject: Research Design
subject: Risk Factors
subject: Self Report
subject: Young Adult

description: 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.