A prospective cohort study in patients with type 2 diabetes mellitus for validation of biomarkers (PROVALID) –study design and baseline characteristics

Eder, S. et al. (2018) A prospective cohort study in patients with type 2 diabetes mellitus for validation of biomarkers (PROVALID) –study design and baseline characteristics. Kidney and Blood Pressure Research, 43(1), pp. 181-190. (doi: 10.1159/000487500)

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Background/Aims: The prevalence of diabetes mellitus type 2 and kidney disease in these patients varies widely between European countries. Methods: In addition to store biosamples 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. Results: 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). Conclusion: 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.

Item Type:Articles
Glasgow Author(s) Enlighten ID:Mark, Professor Patrick
Authors: Eder, S., Leierer, J., Kerschbaum, J., Rosivall, L., Wiecek, A., de Zeeuw, D., Mark, P. B., Heinze, G., Rossing, P., Heerspink, H. L., and Mayer, G.
Subjects:R Medicine > RC Internal medicine
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Kidney and Blood Pressure Research
Publisher:Karger Publishers
ISSN (Online):1423-0143
Published Online:21 February 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in Kidney and Blood Pressure Research 43(1): 181-190
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
508901sysKID (PROVALID Study)Alan JardineEuropean Commission (EC)N/ARI CARDIOVASCULAR & MEDICAL SCIENCES