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Kidney Blood Press Res. 2018;43(1):181-190. doi: 10.1159/000487500. Epub 2018 Feb 16.

A Prospective Cohort Study in Patients with Type 2 Diabetes Mellitus for Validation of Biomarkers (PROVALID) - Study Design and Baseline Characteristics.

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Department of Internal Medicine IV (Nephrology and Hypertension), Medical University Innsbruck, Innsbruck, Austria.
International Nephrology Research and Training Center, Institute of Pathophysiology, Semmelweis University, Budapest, Hungary.
Department of Nephrology, Endocrinology and Metabolic Diseases, Medical University of Silesia, Katowice, Poland.
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University Vienna, Vienna, Austria.
Novo Nordisk Foundation Center for Basic Metabolic Research, Metabolism Center, University of Copenhagen, Copenhagen, Denmark.



The prevalence of diabetes mellitus type 2 and kidney disease in these patients varies widely between European countries.


In addition to store bio-samples the "Prospective cohort study in patients with type 2 diabetes mellitus for validation of biomarkers" collects information on history, physical status, laboratory measurements and medication in 4000 patients with diabetes mellitus type 2, being taken care of at the primary level of healthcare in 5 European countries (Austria, Hungary, Netherlands, Poland and Scotland). Next to comparing the rate of loss of eGFR between the countries, a further objective of the PROVALID study is to determine the 5-year cumulative incidence of renal and cardiovascular outcomes.


The mean age of the population recruited is 62.9±10 years, 54.6% are male and the mean BMI is 30.9±5.4 kg/m2. Metabolic control (median HBA1c 6.8 % (6.2; 7.5)) is achieved via administration of metformin in 67.4% of the patients and insulin in 30.3%. Median systolic and diastolic blood pressure at recruitment is 135 (125; 146) and 80 (72; 85) mmHg, 65.4% of subjects received RAAS blocking agents. Mean eGFR is 80.7±29.2 ml/min/1.73m2 and median baseline albumin/creatinine ratio 8.3 mg (IQR: 3.8 and 25.1).


PROVALID will provide information on incidence and progression of renal and cardiovascular disease and therapy in patients with type 2 diabetes mellitus in different European countries. Thus, in contrast to many other cohort studies we will be able to associate national clinical practise pattern with outcome in this highly vulnerable patient population.


Diabetes mellitus type 2; Diabetic kidney disease; Epidemiology; Health care practice; Treatment

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