Clinical trials, mostly performed in specialist secondary care centra, indicate that intensive diabetes treatment can result in significant health gains. Yet, it is unclear whether these positive results are reflected in primary care practice. Only a small fraction of the usually very homogeneous trial population will be represented. In “real-life” the diabetes type 2 population is much more heterogeneous (e.g. more comorbidities, non-adherence, polypharmacy, different lab values etc), all requiring a more personalized approach. GIANTT research can provide evidence for these more personalized treatments of primary care patients.
The GIANTT cohort offer opportunities for indepth longitudinal and cross-sectional observational research in a representative primary care population of patients with type 2 diabetes in the Northern-Netherlands. Studies could e.g. focus on prescription pattersn (over time), impact of policy and interventions on different labvalues and patient outcomes or medication adherence.
The Dutch population of the international PROVALID cohort study is embedded in the GIANTT cohort. A short description of the PROVALID study is provided below.
One of the most devastating complications of diabetes is nephropathy and despite diabetes being the main cause of end stage renal disease in industrialzed nations the incidence also varies considerably within Europe. In 2008 in Austria 29% of incident dialysis patients had diabetic nephropathy, a number much different from the one observed in the Netherlands (14.6%) or Scotland (6.5%). Whereas in Austria the prevalence of patients with type I diabetes on dialysis was 52.9 per million population (pmp), the number for subjects with type II disease was 149.3. In the Netherlands the corresponding figures were 35.9 and 57.9 and in Scotland 80.7 and 25.5 . The reasons for these discrepancies are unclear as no large scale national epidemiological databases are available reporting the exact incidence and rate of progression of diabetic nephropathy as well as cardiovascular morbidity and mortality of diabetics with and without nephropathy. PROVALID will be an indefinite, prospective cohort study in patients with type II diabetes in five European countries (Austria, Hungary, Netherlands, Poland and Scotland). The patients will be treated according to local practice and followed for the incidence of renal and cardiovascular outcomes as well as mortality.
PROVALID will have 3 major objectives:
- Determine the cumulative incidence of renal outcomes in patients with type II diabetes in different European countries.
- Collection of blood and urine specimen at patient inclusion to allow validation of biomarkers potentially of use in renal disease diagnosis, prognosis, prevention and therapy at the genome, transcriptome, proteome and metabolome level after 5 years
- Determine the cumulative incidence of cardiovascular outcomes in patients with type II diabetes in different European countries.
Patients in the Netherlands
Patients who participate in PROVALID are recruited via the GIANTT network in the city of Groningen, Haren, Delfzijl and Winschoten. A total of 900 patients participate.