The Impact of Diabetes on Patients with Glomerular Disease: CureGN-Diabetes

ABSTRACT Primary glomerular diseases often occur in patients with prexisting diabetes mellitus, a common and systemic illness which increases the risk for infection, cardiovascular and progressive chronic kidney disease. The diagnosis, pathology, treatment, complications and outcomes of primary glomerular diseases may be modified by the risks associated with diabetes, however, the literature is greatly lacking in this area. Such information is crucial to optimizing beneficial therapies and minimizing complications and cost in the care of glomerular disease patients. CureGN-Diabetes is a prospective, longitudinal observational study of patients with one of the four most common primary glomerular diseases: IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), and membranous nephropathy (MN). It is an ancillary study to the parent CureGN study which is currently in its second cycle of NIH/NIDDK funding and has enrolled 2400 patients with IgAN, FSGS, MCD and MN, but excluded patients with diabetes prevalent at the time of glomerular disease diagnosis. The exclusion of diabetes had an unexpected and disproportionate effect on recruitment among minorities and sites in the southeastern U.S., as these populations suffer among the highest rates of diabetes. CureGN-Diabetes will fill this gap in the CureGN study and will also leverage control data from the TRIDENT Study, a longitudinal cohort of patients with biopsy proven diabetic glomerulosclerosis. Harmonization of data from CureGN, TRIDENT and CureGN-Diabetes, will provide an opportunity to study the effects of primary glomerular disease alone, diabetic glomerulosclerosis alone and the combined effects of primary glomerular disease AND diabetes. The aims of CureGN-GN Diabetes include: 1) To recruit and follow a multiethnic cohort of 300 adult patients with diabetes mellitus and biopsy documented IgAN, FSGS, MN, and MCD; 2) To assess the impact of diabetes on presenting features (clinical and histopathologic) and long term outcomes in patients with IgAN, FSGS, MN, and MCD; AND 3) To identify individual and clusters of morphologic lesions which carry diagnostic and prognostic value. A strength of this study is the significant overlap between investigators and clinical sites involved in the CureGN and TRIDENT studies, which will expedite the efficiency and productivity emanating from this work. Furthermore, the CureGN-Diabetes Study will add to the available biorepositories of CureGN and TRIDENT, enriching the resources for future biomarker and mechanistic studies of primary glomerular disease versus diabetes-mediated pathways