Study of Kidney Biopsy and Biomarkers in Adults With Type 2 Diabetes and Severe Kidney Protein Loss to Understand Diabetic Kidney Disease

What this Trial Is About

Researchers are conducting a prospective, observational study involving 300 patients with Type 2 diabetes and macroalbuminuria to better understand diabetic kidney disease DKD, the leading cause of end-stage kidney failure. The study aims to improve diagnosis and personalized treatment by analyzing kidney biopsy samples alongside various biomarkers from blood, feces, urine, and molecular profiles. This multi-center project bridges diabetology, nephrology, biochemistry, and pathology to deepen insight into DKD progression and risks. Participants will undergo research kidney biopsies and provide samples for proteomic, metabolomic, and genetic analysis. These biopsies and biomarkers will be examined using advanced molecular techniques and linked to disease progression and clinical outcomes. The study will follow participants over 20 years to observe changes and outcomes related to kidney health, cardiovascular events, and mortality. Throughout the study, participants will be monitored with kidney biopsies, blood and urine tests, and analyses of microbiome and genetic variations. Researchers will track annual kidney function decline, albumin levels, cardiovascular events, and diabetic retinopathy. The primary outcome is the prevalence of biopsy-proven diabetic nephropathy over the initial 3 years, with ongoing follow-up for disease progression and complications until the studys end.

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors