Rationale and design of the Innsbruck Diabetic Kidney Disease Cohort (IDKDC)—a prospective study investigating etiology and progression of early-stage chronic kidney disease in type 2 diabetes

Abstract

Background The development of chronic kidney disease (CKD) in about 20-40 % of patients with type 2 diabetes (T2D) aggravates cardiovascular morbidity and mortality. Pathophysiology is of increasing relevance for individual management and prognosis, though it is largely unknown among T2D patients with CKD as histologic work-up is not routinely performed upon typical clinical presentation. However, as clinical parameters do not appropriately reflect underlying kidney pathology, reluctance regarding timely histologic assessment in T2D patients with CKD should be critically questioned. Aim As the etiology of CKD in T2D is heterogeneous, we aim to assess the prevalence and clinical disease course of typical diabetic vs. atypical/non-specific vs. non–diabetic vs. coexisting kidney pathologies among T2D patients with mild-to-moderate kidney impairment (KDIGO stage G3a/A1-3 or G2/A2-3; i.e. eGFR 59-45 ml/min irrespective of albuminuria or eGFR 89-60 ml/min and albuminuria >30 mg/g creatinine). Methods The Innsbruck Diabetic Kidney Disease Cohort (IDKDC) study aims to enroll at least 65 T2D patients with mild-to-moderate kidney impairment to undergo a diagnostic kidney biopsy. 6 monthly clinical follow-ups for up to 5 years will provide clinical and laboratory data to assess cardio-renal outcomes. Blood, urine and kidney tissue specimen will be biobanked to identify diagnostic and prognostic biomarkers. Conclusions While current risk assessment is primarily based on clinical parameters, our study will provide the scientific background for a potential change of the diagnostic standard towards routine kidney biopsy and clarify its role for individual risk prediction regarding cardio-renal outcome in T2D patients with mild-to-moderate kidney impairment.