title: Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2.
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.
  
  
  CONCLUSIONS
  DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies.
authors: Department of Internal Medicine II, Nephrology, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93042, Regensburg, Germany.
authors: Lena
authors: L
authors: Dörhöfer
authors: Alexander
authors: A
authors: Lammert
authors: Vera
authors: V
authors: Krane
authors: Mathias
authors: M
authors: Gorski
authors: Bernhard
authors: B
authors: Banas
authors: Christoph
authors: C
authors: Wanner
authors: Bernhard K
authors: BK
authors: Krämer
authors: Iris M
authors: IM
authors: Heid
authors: Carsten A
authors: CA
authors: Böger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018070:Biological Specimen Banks; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000208:ethnology / Q000209:etiology; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000453:epidemiology* / Q000208:ethnology; D003928:Diabetic Nephropathies / Q000453:epidemiology* / Q000208:ethnology; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology / Q000208:ethnology / Q000209:etiology; D008875:Middle Aged; D010641:Phenotype; D010808:Physical Examination; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology* / Q000208:ethnology / Q000209:etiology; D012107:Research Design; D012307:Risk Factors; D057566:Self Report; D044465:White People / Q000208:ethnology; D055815:Young Adult