Abstract

The GenoDiabMar registry is a prospective study that aims to provide data on demographic, biochemical, and clinical changes in type 2 diabetic (T2D) patients attending real medical outpatient consultations. This registry is also used to find new biomarkers related to the micro- and macrovascular complications of T2D, with a particular focus on diabetic nephropathy. With this purpose, longitudinal serum and urine samples, DNA banking, and data on 227 metabolomics profiles, 77 immunoglobulin G glycomics traits, and other emerging biomarkers were recorded in this cohort. In this study, we show a detailed longitudinal description of the clinical and analytical parameters of this registry, with a special focus on the progress of renal function and cardiovascular events. The main objective is to analyze whether there are differential risk factors for renal function deterioration between sexes, as well as to analyze cardiovascular events and mortality in this population. In total, 650 patients with a median age of 69 (14) with different grades of chronic kidney disease—G1–G2 (eGFR > 90–60 mL/min/1.73 m2) 50.3%, G3 (eGFR; 59–30 mL/min/1.73 m2) 31.4%, G4 (eGFR; 29–15 mL/min/1.73 m2) 10.8%, and G5 (eGFR < 15 mL/min/1.73 m2) 7.5%—were followed up for 4.7 (0.65) years. Regardless of albuminuria, women lost 0.93 (0.40–1.46) fewer glomerular filtration units per year than men. A total of 17% of the participants experienced rapid deterioration of renal function, 75.2% of whom were men, with differential risk factors between sexes—severe macroalbuminuria > 300 mg/g for men OR [IQ] 2.40 [1.29:4.44] and concomitant peripheral vascular disease 3.32 [1.10:9.57] for women. Overall mortality of 23% was detected (38% of which was due to cardiovascular etiology). We showed that kidney function declined faster in men, with different risk factors compared to women. Patients with T2D and kidney involvement have very high mortality and an important cardiovascular burden. This cohort is proposed as a great tool for scientific collaboration for studies, whether they are focused on T2D, or whether they are interested in comparing differential markers between diabetic and non-diabetic populations.

Highlights

  • Diabetes mellitus is of pandemic proportions, affecting more than 450 million people worldwide, of whom up to 95% have type 2 diabetes [1]

  • Pie chart shows causes of mortality distributed in in percentages. This is a well-characterized registry with information on longitudinal micro- and macrovascular complications of type 2 diabetic (T2D), as well as detailed clinical and analytical information

  • We have provided a detailed picture of the clinical and analytical behavior of these patients, This is a well-characterized registry with information on longitudinal microand so as to facilitate detailed knowledge of the available variables, as well as their distribution macrovascular complications of T2D, as well as detailed clinical and analytical inforand evolution

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Summary

Introduction

Diabetes mellitus is of pandemic proportions, affecting more than 450 million people worldwide, of whom up to 95% have type 2 diabetes [1]. The improvement in prevention strategies and therapeutic interventions has led to a significant reduction in most diabetes complications. This is not so evident in the case of diabetic kidney disease (DKD), which remains the leading cause of end-stage renal disease (ESRD) in Western countries [5,6]. Despite the high prevalence and increasing incidence of this disease, the underlying pathophysiological mechanisms are not fully understood and, even today, highly sensitive and specific diagnostic tests are not available In this way, classical biomarkers used to estimate glomerular filtration rate (eGFR) and renal damage—such as serum creatinine and albuminuria—have well-known limitations [10–14], and may fail in the early detection of kidney impairment

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