Renal Insufficiency And Cardiovascular Events
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor
      of cardiovascular morbidity and mortality in the general population, independent of
      traditional cardiovascular risk factors.

      This observational study is aimed at assessing the association of reduced estimated GFR with
      cardiovascular morbidity and mortality in a large italian population (at least 15,000
      subjects) of type 2 diabetic outpatients over a 4-year follow-up.
    

Detailed description: 
      Reduced GFR has been recently shown to be a powerful predictor of cardiovascular morbidity
      and mortality in the general population, independent of traditional cardiovascular risk
      factors. Since type 2 diabetic patients show increased cardiovascular morbidity and mortality
      as compared with the general population, the identification of predictors of cardiovascular
      disease in these patients is of fundamental importance for clinical purposes. One of these
      predictors is increased urinary albumin excretion rate, which is associated with an increased
      risk of cardiovascular disease more than of end-stage renal disease. However, a growing body
      of evidence indicates that a significant proportion of normoalbuminuric diabetic patients,
      particularly with type 2 diabetes, may exhibit reduced GFR. It is currently unknown the
      predictive role of this abnormality toward cardiovascular events and death, independent of
      albuminuria and other known risk factors, in the diabetic population.

      This observational study is aimed at assessing the association of reduced estimated GFR with
      cardiovascular morbidity and mortality in a large italian population (at least 15,000
      subjects) of type 2 diabetic nondialytic outpatients over a 4-year follow-up.

      Secondary endpoints are to assess in this population:

        -  the prevalence and incidence of reduced GFR, as classified according to the National
           Kidney Foundation criteria, and its association with traditional cardiovascular risk
           factors;

        -  the prevalence, incidence and cardiovascular predictivity of micro and macroalbuminuria.

      Patients will be recruited from electronic records of 20 italian outpatients diabetic
      clinics.

      Routine anamnestic, clinical, laboratory and instrumental data will be recorded at baseline
      and over 4 years to obtain information about:

        -  renal function (albumin/creatinine ratio, serum creatinine with estimation of glomerular
           filtration rate [eGFR]);

        -  cardiovascular risk factors (smoking, physical activity, family history of diabetes,
           dyslipidemia, hypertension and cardiovascular disease, BMI and waist circumference,
           total, LDL, HDL and non-HDL cholesterol, triglycerides, arterial blood pressure and
           HbA1c);

        -  current glucose-, lipid- and blood pressure-lowering and anti-platelet or anti-coagulant
           treatment;

        -  other illnesses;

        -  cardiovascular events (myocardial infarction, stroke, lower limb
           ulcer/gangrene/amputation and coronary, carotid and lower limb revascularization,
           endovascular/surgical) and deaths.

      These data will be derived from the electronic database of each participating center.

      Laboratory analyses will be performed in each centre laboratory after proper standardization
      of analytical techniques.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients clinics
      
Keywords: Type 2 diabetes; Cardiovascular disease; Diabetic Nephropathy; Glomerular filtration rate; Albuminuria