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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Susanne Eder
  • Johannes Leierer
  • Julia Kerschbaum
  • Laszlo Rosivall
  • Andrzej Wiecek
  • Dick de Zeeuw
  • Patrick B Mark
  • Georg Heinze
  • Peter Rossing
  • Hiddo L Heerspink
  • Gert Mayer
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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 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.

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.

OriginalsprogEngelsk
TidsskriftKidney & blood pressure research
Vol/bind43
Udgave nummer1
Sider (fra-til)181-190
Antal sider10
ISSN1420-4096
DOI
StatusUdgivet - 2018
Eksternt udgivetJa

ID: 54955590