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PROVALID – prospective multinational cohort study in patients with type 2 diabetes treated in primary care

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Title:  PROVALID – prospective multinational cohort study in patients with type 2 diabetes treated in primary care
Investigator: Hiddo Lambers Heerspink, Paul Smink, Bettine Haandrikman, Jan Roggeveld, Stephan Bakker
Supervisor:   Dick de Zeeuw
Summary:  PROVALID is an indefinite, prospective cohort study in 4.000 individuals with type II diabetes in five European countries (Austria, Hungary, Netherlands, Poland and Scotland). The patients will be followed and treated according to local practice.
The primary objective from PROVALID is to determine the cumulative incidence of renal outcomes in patients with type II diabetes in different European countries. Renal outcomes are defined as:
  • Progression from normoalbuminuria to microalbuminuria (including > 30% increase in albuminuria from baseline)
  • Progression from microalbuminuria to macroalbuminuria (including > 30% increase in albuminuria from baseline)
  • Progression to doubling of serum creatinine, end stage renal disease (ESRD) or death


Secondary objective is to collect blood and urine specimen to allow validation fo biomarkers potentially of use in renal disease diagnosis, prognosis and prevention.

Financing:  sysKID Project (EU FP-7 project) and Abbvie
Start:  01-01-2010
End:  01-01-2017  

Projects
The use of a multiple parameter response efficacy score to predict the effect of a drug on hard renal and cardiovascular
Diabetes Mellitus Treatment for Renal Insufficiency Consortium (DIAMETRIC) database 
System biology approach for discovery of biomarkers of renal disease progressioni in diabetes (SysKid)
PROVALID – prospective multinational cohort study in patients with type 2 diabetes treated in primary care
Vitamin-D deficiency as a risk marker for renal and CV complications in the general population
A novel approach of personalized medicine: considering multiple effects of a single drug
Optimal hard endpoints in clinical trials of renal disease progression
Albuminuria as surrogate endpoint in clinical trials
Individual therapy response to a sodium-glucose transport inhibitor
Involving patients in the assessment and evaluation of medication treatment
Groningen Initiative to Analyse Type-2 diabetes Treatment ( GIANTT )
The role of medication adherence in predicting treatment response and estimating cost-effectiveness of statin treatment
Pharmacogenetics and response to treatment of oral antidiabetics
Quality of prescribing: patient specific indicators that predict better outcomes in diabetes patients
Quality assessment of pharmacotherapy in patients with chronic kidney disease
Cost effectiveness of ACEi and ARBs on renal failure in diabetes patients
Drug information and risk communication in Africa
Regulatory Science Projects