Renal Insufficiency And Cardiovascular Events (RIACE)
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| ClinicalTrials.gov Identifier: NCT00715481 |
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Recruitment Status :
Completed
First Posted : July 15, 2008
Last Update Posted : February 10, 2015
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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.
| Condition or disease |
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| Cardiovascular Disease |
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.
| Study Type : | Observational |
| Actual Enrollment : | 15628 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Reduced Estimated Glomerular Filtration Rate (eGFR)and Prediction of Cardiovascular Disease and Renal Outcome in Subjects With Type 2 Diabetes: Italian Multicenter Study |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | February 2015 |
- cardiovascular morbidity and mortality [ Time Frame: 4 years ]
- eGFR, as classified according to the National Kidney Foundation criteria [ Time Frame: 4 years ]
- micro/macroalbuminuria [ Time Frame: 4 years ]
- traditional cardiovascular risk factors [ Time Frame: 4 years ]
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
type 2 diabetes
Exclusion Criteria:
dyalisis or renal transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715481
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| Principal Investigator: | Giuseppe Pugliese, MD, PhD | Diabetic Nephropathy Study Group | |
| Study Director: | Anna Solini, MD, PhD | Diabetic Nephropathy Study Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Giuseppe Pugliese, Professor of Endocrinology and Metabolism, Diabetic Nephropathy Study Group |
| ClinicalTrials.gov Identifier: | NCT00715481 |
| Other Study ID Numbers: |
DNSG-SID 0601 |
| First Posted: | July 15, 2008 Key Record Dates |
| Last Update Posted: | February 10, 2015 |
| Last Verified: | February 2015 |
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Type 2 diabetes Cardiovascular disease Diabetic Nephropathy Glomerular filtration rate Albuminuria |
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Cardiovascular Diseases |