| 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.
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